The Efficacy of Non-invasive Brain Stimulation on Cognitive Functions in Patients With Chronic Obstructive Pulmonary Disease: Double-Blinded Randomised Controlled Trial

NCT07332169 | Not Yet Recruiting DMC

• 2 other identifiers: IRB-PGS-2025-03-0600IRB-PGS-2025-03-0553
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to examine if non-invasive brain stimulation (NIBS) can enhance cognitive function with chronic obstructive pulmonary disease (COPD) population. The main questions it aims to answer are:

• What is the possibility effect of using the NIBS on cognitive functions as well as the cardiopulmonary parameters in COPD population?
• What is the relation between cognitive function parameters and cardiopulmonary parameters in COPD population who suffer from cognitive impairment (CI)? Researchers will compare NIBS to a sham-NIBS to see if NIBS works to improve cognitive function in COPD population. Participants will: Receive NIBS or a sham-NIBS 5 sessions/week for 3 weeks for 20 min each session. Visit the clinic at the beginning for baseline assessment then after the completion of the 3 weeks to reassess them. Outcome measures for cognitive parameters and pulmonary parameters will be taken pre and post NIBS intervention

Conditions

COPD; COPD (Chronic Obstructive Pulmonary Disease); Cognitive Impairment (CI); Non-invasive Brain Stimulation

Keywords

COPD; NIBS; non-invasive brain stimulation; cognitive function; cognitive impairment

Outcome Measures

Primary Outcomes (1)

• The battery of neurocognitive tests

  • Neuropsychological tests are going to be utilised to evaluate cognitive function. • The two key domains to be evaluated are memory and attention. • The Flanker Task will test the attention domain by examining how well the executive control network can be modulated by focusing on one stimulus while concurrently preventing the detection of another stimulus. • The Memory Automaticity Task will be used to evaluate working memory, requiring participants to complete Sternberg-style memory searches in order to attain automaticity; Recalling the existence of a specific letter in the memory set and accurately classifying it are prerequisites for this task. - The previously trained researcher will administer the test.

  At enrolment as baseline assessment and at the end of treatment at 3 weeks

Secondary Outcomes (3)

• Cardiopulmonary exercise test (CPET)

  At enrolment as baseline assessment and at the end of treatment at 3 weeks

• Transcranial Doppler (TCD) ultrasound

  At enrolment as baseline assessment and at the end of treatment at 3 weeks

• Arterial blood gas analysis (ABGs)

  At enrolment as baseline assessment and at the end of treatment at 3 weeks

Other Outcomes (1)

• Montreal Cognitive Assessment (MoCA) Test

  Stratification outcome measure only at the beginning of the study

Study Arms (2)

Non-invasive brain stimulation

EXPERIMENTAL

Sinusoidal current used between two electrodes on the dorsolateral prefrontal cortex (DLPFC) area. - Gamma-Transcranial Alternating Current Stimulation (tACS) of 2 mA at 40 Hz will be given to the experimental group. - Session duration will last 20 minutes, of 5 session/week, for 3weeks.

Device: Non-invasive brain stimulation

Sham Non-invasive brain stimulation

SHAM COMPARATOR

Sinusoidal current used between two electrodes on the dorsolateral prefrontal cortex (DLPFC) area. - To maintain this stimulation's indistinguishability from the experimental stimulation, the control group will be given an electric current that ramps down 60 seconds after the stimulation begins. - Session duration will last 20 minutes, of 5 session/week, for 3weeks.

Device: Sham Non-Invasive brain stimulation

Interventions

Sham Non-Invasive brain stimulation DEVICE

Non-invasive brain stimulation (NIBS) modifies brain activity without surgery using electric currents. - Transcranial alternating current stimulation (tACS) is one type of NIBS that modifies neuronal oscillations in the brain by applying alternating electrical currents to the scalp through electrodes. - This method can enhance motor abilities, improve cognitive functions, and be used in rehabilitation. - It does this by entraining neurones, which synchronise their firing to the applied sinusoidal frequency. The electric current used as ramps down 60 seconds after the stimulation begins.

Also known as: NIBS

Sham Non-invasive brain stimulation

Non-invasive brain stimulation DEVICE

Non-invasive brain stimulation (NIBS) modifies brain activity without surgery using electric currents. - Transcranial alternating current stimulation (tACS) is one type of NIBS that modifies neuronal oscillations in the brain by applying alternating electrical currents to the scalp through electrodes. - This method can enhance motor abilities, improve cognitive functions, and be used in rehabilitation. - It does this by entraining neurones, which synchronise their firing to the applied sinusoidal frequency. Gamma-Transcranial Alternating Current Stimulation (tACS) of 2 mA at 40 Hz will be given to the experimental group.

Also known as: NIBS

Non-invasive brain stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult age from eighteen years old and above.
• Patients with confirmed COPD via pulmonary function test (PFT) according to the classifications of GOLD.
• All stages of GOLD will be included
• Stable patients, which means they were not admitted to the hospital in the last 3 months
• Patients with COPD with confirmed cognitive impairment by MoCA test.
• All MoCA stages will be included.

You may not qualify if:

• Patients without COPD
• Unstable patients with several admission in the last 3 months
• Patients with COPD but without cognitive impairment.
• COPD patients who suffered from any neurological problems
• COPD patients who are contraindicated for using brain stimulation like psychiatric disorders.

Sponsors & Collaborators

• Shahad Abdulrahman Alkandari: lead
• Imam Abdulrahman Bin Faisal University: collaborator

Study Sites (1)

Imam Abdulrahman Bin Faisal University

Dammam, Saudi Arabia

Location

Related Publications (47)

• Woods AJ, Antal A, Bikson M, Boggio PS, Brunoni AR, Celnik P, Cohen LG, Fregni F, Herrmann CS, Kappenman ES, Knotkova H, Liebetanz D, Miniussi C, Miranda PC, Paulus W, Priori A, Reato D, Stagg C, Wenderoth N, Nitsche MA. A technical guide to tDCS, and related non-invasive brain stimulation tools. Clin Neurophysiol. 2016 Feb;127(2):1031-1048. doi: 10.1016/j.clinph.2015.11.012. Epub 2015 Nov 22.

  PMID: 26652115 BACKGROUND

• Lefaucheur JP, Antal A, Ayache SS, Benninger DH, Brunelin J, Cogiamanian F, Cotelli M, De Ridder D, Ferrucci R, Langguth B, Marangolo P, Mylius V, Nitsche MA, Padberg F, Palm U, Poulet E, Priori A, Rossi S, Schecklmann M, Vanneste S, Ziemann U, Garcia-Larrea L, Paulus W. Evidence-based guidelines on the therapeutic use of transcranial direct current stimulation (tDCS). Clin Neurophysiol. 2017 Jan;128(1):56-92. doi: 10.1016/j.clinph.2016.10.087. Epub 2016 Oct 29.

  PMID: 27866120 BACKGROUND

• Antal A, Alekseichuk I, Bikson M, Brockmoller J, Brunoni AR, Chen R, Cohen LG, Dowthwaite G, Ellrich J, Floel A, Fregni F, George MS, Hamilton R, Haueisen J, Herrmann CS, Hummel FC, Lefaucheur JP, Liebetanz D, Loo CK, McCaig CD, Miniussi C, Miranda PC, Moliadze V, Nitsche MA, Nowak R, Padberg F, Pascual-Leone A, Poppendieck W, Priori A, Rossi S, Rossini PM, Rothwell J, Rueger MA, Ruffini G, Schellhorn K, Siebner HR, Ugawa Y, Wexler A, Ziemann U, Hallett M, Paulus W. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines. Clin Neurophysiol. 2017 Sep;128(9):1774-1809. doi: 10.1016/j.clinph.2017.06.001. Epub 2017 Jun 19.

  PMID: 28709880 BACKGROUND

• Manippa V, Palmisano A, Nitsche MA, Filardi M, Vilella D, Logroscino G, Rivolta D. Cognitive and Neuropathophysiological Outcomes of Gamma-tACS in Dementia: A Systematic Review. Neuropsychol Rev. 2024 Mar;34(1):338-361. doi: 10.1007/s11065-023-09589-0. Epub 2023 Mar 6.

  PMID: 36877327 BACKGROUND

• Chaieb L, Antal A, Pisoni A, Saiote C, Opitz A, Ambrus GG, Focke N, Paulus W. Safety of 5 kHz tACS. Brain Stimul. 2014 Jan-Feb;7(1):92-6. doi: 10.1016/j.brs.2013.08.004. Epub 2013 Sep 13.

  PMID: 24064065 BACKGROUND

• Bikson M, Datta A, Elwassif M. Establishing safety limits for transcranial direct current stimulation. Clin Neurophysiol. 2009 Jun;120(6):1033-4. doi: 10.1016/j.clinph.2009.03.018. Epub 2009 Apr 24. No abstract available.

  PMID: 19394269 BACKGROUND

• Zhou D, Li A, Li X, Zhuang W, Liang Y, Zheng CY, Zheng H, Yuan TF. Effects of 40 Hz transcranial alternating current stimulation (tACS) on cognitive functions of patients with Alzheimer's disease: a randomised, double-blind, sham-controlled clinical trial. J Neurol Neurosurg Psychiatry. 2022 May;93(5):568-570. doi: 10.1136/jnnp-2021-326885. Epub 2021 Nov 11. No abstract available.

  PMID: 34764150 BACKGROUND

• Antal A, Herrmann CS. Transcranial Alternating Current and Random Noise Stimulation: Possible Mechanisms. Neural Plast. 2016;2016:3616807. doi: 10.1155/2016/3616807. Epub 2016 May 3.

  PMID: 27242932 BACKGROUND

• Guerra A, Suppa A, Bologna M, D'Onofrio V, Bianchini E, Brown P, Di Lazzaro V, Berardelli A. Boosting the LTP-like plasticity effect of intermittent theta-burst stimulation using gamma transcranial alternating current stimulation. Brain Stimul. 2018 Jul-Aug;11(4):734-742. doi: 10.1016/j.brs.2018.03.015. Epub 2018 Mar 24.

  PMID: 29615367 BACKGROUND

• Antal A, Boros K, Poreisz C, Chaieb L, Terney D, Paulus W. Comparatively weak after-effects of transcranial alternating current stimulation (tACS) on cortical excitability in humans. Brain Stimul. 2008 Apr;1(2):97-105. doi: 10.1016/j.brs.2007.10.001. Epub 2007 Dec 3.

  PMID: 20633376 BACKGROUND

• GOLD. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease 2023 REPOR. 2023.

  BACKGROUND

• Tahasildar KK, Shrawasti SJ, Shete JS. Study of Arterial Blood Gas Analysis (ABG) in Patients of Obstructive Airway Diseases in Accordance with Clinical Correlation. Res J Med Sci. 2024;18:341-5.

  BACKGROUND

• Dash M, Apsara N, Chitra A. ABG Analysis and its Interpretation. Acta Scientific Paediatrics. 2019;2(10):108-11.

  BACKGROUND

• Bonow RH, Young CC, Bass DI, Moore A, Levitt MR. Transcranial Doppler ultrasonography in neurological surgery and neurocritical care. Neurosurg Focus. 2019 Dec 1;47(6):E2. doi: 10.3171/2019.9.FOCUS19611.

  PMID: 31786564 BACKGROUND

• Purkayastha S, Sorond F. Transcranial Doppler ultrasound: technique and application. Semin Neurol. 2012 Sep;32(4):411-20. doi: 10.1055/s-0032-1331812. Epub 2013 Jan 29.

  PMID: 23361485 BACKGROUND

• Guazzi M, Arena R, Halle M, Piepoli MF, Myers J, Lavie CJ. 2016 Focused Update: Clinical Recommendations for Cardiopulmonary Exercise Testing Data Assessment in Specific Patient Populations. Circulation. 2016 Jun 14;133(24):e694-711. doi: 10.1161/CIR.0000000000000406. Epub 2016 May 2.

  PMID: 27143685 BACKGROUND

• Shiffrin R, Schneider W. Controlled and automatic human information processing: II. Perceptual learning, automatic attending and a general theory. Psychological Review. 1977;84:127-90.

  BACKGROUND

• Diamond A. Executive functions. Annu Rev Psychol. 2013;64:135-68. doi: 10.1146/annurev-psych-113011-143750. Epub 2012 Sep 27.

  PMID: 23020641 BACKGROUND

• Nasreddine ZS, Phillips NA, Bédirian V, Charbonneau S, Whitehead V, Collin I, et al. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005;53(4):695-9.

  BACKGROUND

• Rahman TT, El Gaafary MM. Montreal Cognitive Assessment Arabic version: reliability and validity prevalence of mild cognitive impairment among elderly attending geriatric clubs in Cairo. Geriatr Gerontol Int. 2009 Mar;9(1):54-61. doi: 10.1111/j.1447-0594.2008.00509.x.

  PMID: 19260980 BACKGROUND

• Kaya M, Gurses HN, Ucgun H, Okyaltirik F. Effects of creative dance on functional capacity, pulmonary function, balance, and cognition in COPD patients: A randomized controlled trial. Heart Lung. 2023 Mar-Apr;58:13-20. doi: 10.1016/j.hrtlng.2022.10.017. Epub 2022 Nov 3.

  PMID: 36335909 BACKGROUND

• Leitao J, Thielscher A, Tunnerhoff J, Noppeney U. Concurrent TMS-fMRI Reveals Interactions between Dorsal and Ventral Attentional Systems. J Neurosci. 2015 Aug 12;35(32):11445-57. doi: 10.1523/JNEUROSCI.0939-15.2015.

  PMID: 26269649 BACKGROUND

• Hsueh JJ, Chen TS, Chen JJ, Shaw FZ. Neurofeedback training of EEG alpha rhythm enhances episodic and working memory. Hum Brain Mapp. 2016 Jul;37(7):2662-75. doi: 10.1002/hbm.23201. Epub 2016 Apr 1.

  PMID: 27038114 BACKGROUND

• Shen J, Zhang G, Yao L, Zhao X. Real-time fMRI training-induced changes in regional connectivity mediating verbal working memory behavioral performance. Neuroscience. 2015 Mar 19;289:144-52. doi: 10.1016/j.neuroscience.2014.12.071. Epub 2015 Jan 13.

  PMID: 25595984 BACKGROUND

• Rostami M, Lee A, Frazer AK, Akalu Y, Siddique U, Pearce AJ, Tallent J, Kidgell DJ. Determining the effects of transcranial alternating current stimulation on corticomotor excitability and motor performance: A sham-controlled comparison of four frequencies. Neuroscience. 2025 Mar 5;568:12-26. doi: 10.1016/j.neuroscience.2025.01.016. Epub 2025 Jan 10.

  PMID: 39798837 BACKGROUND

• Soleimani G, Kupliki R, Bodurka J, Paulus MP, Ekhtiari H. How structural and functional MRI can inform dual-site tACS parameters: A case study in a clinical population and its pragmatic implications. Brain Stimul. 2022 Mar-Apr;15(2):337-351. doi: 10.1016/j.brs.2022.01.008. Epub 2022 Jan 15.

  PMID: 35042056 BACKGROUND

• Chen J, Lin IT, Zhang H, Lin J, Zheng S, Fan M, Zhang J. Reduced cortical thickness, surface area in patients with chronic obstructive pulmonary disease: a surface-based morphometry and neuropsychological study. Brain Imaging Behav. 2016 Jun;10(2):464-76. doi: 10.1007/s11682-015-9403-7.

  PMID: 25986304 BACKGROUND

• MacDonald AW 3rd, Cohen JD, Stenger VA, Carter CS. Dissociating the role of the dorsolateral prefrontal and anterior cingulate cortex in cognitive control. Science. 2000 Jun 9;288(5472):1835-8. doi: 10.1126/science.288.5472.1835.

  PMID: 10846167 BACKGROUND

• Fried PJ, Santarnecchi E, Antal A, Bartres-Faz D, Bestmann S, Carpenter LL, Celnik P, Edwards D, Farzan F, Fecteau S, George MS, He B, Kim YH, Leocani L, Lisanby SH, Loo C, Luber B, Nitsche MA, Paulus W, Rossi S, Rossini PM, Rothwell J, Sack AT, Thut G, Ugawa Y, Ziemann U, Hallett M, Pascual-Leone A. Training in the practice of noninvasive brain stimulation: Recommendations from an IFCN committee. Clin Neurophysiol. 2021 Mar;132(3):819-837. doi: 10.1016/j.clinph.2020.11.018. Epub 2020 Dec 3.

  PMID: 33549501 BACKGROUND

• Amouzadeh F, Sheikh M. Impact of transcranial alternating current stimulation on working memory and selective attention in athletes with attention deficit hyperactivity disorder: randomized controlled trial. Neuroreport. 2022 Dec 14;33(17):756-762. doi: 10.1097/WNR.0000000000001842. Epub 2022 Oct 17.

  PMID: 36250434 BACKGROUND

• Gehrman PR, Bartky EJ, Travers C, Lapidus K. A Fully Remote Randomized Trial of Transcranial Alternating Current Stimulation for the Acute Treatment of Major Depressive Disorder. J Clin Psychiatry. 2024 Apr 22;85(2):23m15078. doi: 10.4088/JCP.23m15078.

  PMID: 38696220 BACKGROUND

• Hendi NI, El-Samahy M, AboEl-Azm YH, Arar A, Ramadan SI, Zedan EM, et al. Efficacy of Transcranial Alternating Current Stimulation (tACS) in Cognition and Memory in Patients with Mild Cognitive Impairement or Alzheimer's Disease. A Systematic Review and Meta-analysis of Randomized Controlled Trials: Alzheimers Dement. 2025 Jan 9;20(Suppl 6):e087903. doi: 10.1002/alz.087903. eCollection 2024 Dec.; 2025.

  BACKGROUND

• Tabka O, Sanaa I, Mekki M, Acheche A, Paillard T, Trabelsi Y. Effect of a pulmonary rehabilitation program combined with cognitive training on exercise tolerance and cognitive functions among Tunisian male patients with chronic obstructive pulmonary disease: A randomized controlled trial. Chron Respir Dis. 2023 Jan-Dec;20:14799731231201643. doi: 10.1177/14799731231201643.

  PMID: 37691169 BACKGROUND

• Lavoie KL, Sedeno M, Hamilton A, Li PZ, De Sousa D, Troosters T, Maltais F, Bourbeau J. Behavioural interventions targeting physical activity improve psychocognitive outcomes in COPD. ERJ Open Res. 2019 Nov 4;5(4):00013-2019. doi: 10.1183/23120541.00013-2019. eCollection 2019 Oct.

  PMID: 31720294 BACKGROUND

• Andrianopoulos V, Gloeckl R, Schneeberger T, Jarosch I, Vogiatzis I, Hume E, Koczulla RA, Kenn K. Benefits of pulmonary rehabilitation in COPD patients with mild cognitive impairment - A pilot study. Respir Med. 2021 Aug-Sep;185:106478. doi: 10.1016/j.rmed.2021.106478. Epub 2021 May 23.

  PMID: 34038843 BACKGROUND

• Bonnevie T, Medrinal C, Combret Y, Debeaumont D, Lamia B, Muir JF, Cuvelier A, Prieur G, Gravier FE. Mid-Term Effects of Pulmonary Rehabilitation on Cognitive Function in People with Severe Chronic Obstructive Pulmonary Disease. Int J Chron Obstruct Pulmon Dis. 2020 May 19;15:1111-1121. doi: 10.2147/COPD.S249409. eCollection 2020.

  PMID: 32546999 BACKGROUND

• France G, Orme MW, Greening NJ, Steiner MC, Chaplin EJ, Clinch L, Singh SJ. Cognitive function following pulmonary rehabilitation and post-discharge recovery from exacerbation in people with COPD. Respir Med. 2021 Jan;176:106249. doi: 10.1016/j.rmed.2020.106249. Epub 2020 Nov 21.

  PMID: 33253973 BACKGROUND

• Turan O, Turan PA, Mirici A. Parameters affecting inhalation therapy adherence in elderly patients with chronic obstructive lung disease and asthma. Geriatr Gerontol Int. 2017 Jun;17(6):999-1005. doi: 10.1111/ggi.12823. Epub 2016 Jul 18.

  PMID: 27426234 BACKGROUND

• Dodd JW. Lung disease as a determinant of cognitive decline and dementia. Alzheimers Res Ther. 2015 Mar 21;7(1):32. doi: 10.1186/s13195-015-0116-3. eCollection 2015.

  PMID: 25798202 BACKGROUND

• Pelgrim CE, Peterson JD, Gosker HR, Schols AMWJ, van Helvoort A, Garssen J, Folkerts G, Kraneveld AD. Psychological co-morbidities in COPD: Targeting systemic inflammation, a benefit for both? Eur J Pharmacol. 2019 Jan 5;842:99-110. doi: 10.1016/j.ejphar.2018.10.001. Epub 2018 Oct 15.

  PMID: 30336140 BACKGROUND

• Yohannes AM, Chen W, Moga AM, Leroi I, Connolly MJ. Cognitive Impairment in Chronic Obstructive Pulmonary Disease and Chronic Heart Failure: A Systematic Review and Meta-analysis of Observational Studies. J Am Med Dir Assoc. 2017 May 1;18(5):451.e1-451.e11. doi: 10.1016/j.jamda.2017.01.014. Epub 2017 Mar 11.

  PMID: 28292570 BACKGROUND

• Lindbergh CA, Dishman RK, Miller LS. Functional Disability in Mild Cognitive Impairment: A Systematic Review and Meta-Analysis. Neuropsychol Rev. 2016 Jun;26(2):129-59. doi: 10.1007/s11065-016-9321-5. Epub 2016 Jul 8.

  PMID: 27393566 BACKGROUND

• Torres-Sanchez I, Rodriguez-Alzueta E, Cabrera-Martos I, Lopez-Torres I, Moreno-Ramirez MP, Valenza MC. Cognitive impairment in COPD: a systematic review. J Bras Pneumol. 2015 Mar-Apr;41(2):182-90. doi: 10.1590/S1806-37132015000004424. Epub 2015 Apr 18.

  PMID: 25909154 BACKGROUND

• Dhakal A, Bobrin BD. Cognitive Deficits. StatPearls. Treasure Island (FL) ineligible companies. Disclosure: Bradford Bobrin declares no relevant financial relationships with ineligible companies.: StatPearls Publishing Copyright © 2023, StatPearls Publishing LLC.; 2023.

  BACKGROUND

• Dodd JW, Getov SV, Jones PW. Cognitive function in COPD. Eur Respir J. 2010 Apr;35(4):913-22. doi: 10.1183/09031936.00125109.

  PMID: 20356988 BACKGROUND

• Ranzini L, Schiavi M, Pierobon A, Granata N, Giardini A. From Mild Cognitive Impairment (MCI) to Dementia in Chronic Obstructive Pulmonary Disease. Implications for Clinical Practice and Disease Management: A Mini-Review. Front Psychol. 2020 Feb 28;11:337. doi: 10.3389/fpsyg.2020.00337. eCollection 2020.

  PMID: 32184750 BACKGROUND

• Samareh Fekri M, Hashemi-Bajgani SM, Naghibzadeh-Tahami A, Arabnejad F. Cognitive Impairment among Patients with Chronic Obstructive Pulmonary Disease Compared to Normal Individuals. Tanaffos. 2017;16(1):34-39.

  PMID: 28638422 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Shahad Alkandari, Master's degree

CONTACT

+96597533309; alkandari-shahad@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Shahad Alkandari MSc, PT.

Model Details: Two groups included: One group will receive the non-invasive brain stimulation, and the other group will receive sham non-invasive brain stimulation.

Study Record Dates

• First Submitted: December 28, 2025
• First Posted: January 12, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): November 30, 2028
• Last Updated: January 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

SA (1)