Effect of Transcranial Direct Current Stimulation (tDCS) on Post-stroke Patients on Neuromotor Recovery

NCT05821816 | Completed DMC

• 1 other identifier: Prot. CE/2022_031
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to evaluate whether a non-invasive brain stimulation technique (Transcranial Direct Current Stimulation) can influence the secondary neurodegeneration observed after a stroke (assessed based on serum concentration of neurofilaments) and can improve the functional outcome.

Conditions

Stroke

Keywords

Stroke; Rehabilitation; tDCS; Neurofilament; Neurofilament light chain; NfL; Transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• To assess the change of blood value of Neurofilament light chain (NfL)

  Evaluation of neurodegeneration after stroke

  Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment

Secondary Outcomes (8)

• To assess the change of the Fugl-Meyer Assessment for upper extremity (FMA-UE)

  Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment

• To assess the change of Modified Ashwort Scale (MAS)

  Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment

• To assess the change of The Rivermead Mobility Index (RMI)

  Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment

• To assess the change of Barthel Index (BI)

  Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment

• To assess the change of Functional Ambulation Categories (FAC)

  Initial assessment: after enrollment. Intermediate evaluation after 6 weeks. Final evaluation after 12 weeks since enrollment

Study Arms (2)

Experimental Group

EXPERIMENTAL

Standard rehabilitative treatment for stroke + tDCS

Device: tDCS; Other: Conventional rehabilitative treatment

Control Group

ACTIVE COMPARATOR

Only standard rehabilitative treatment for stroke

Other: Conventional rehabilitative treatment

Interventions

tDCS DEVICE

Use of Transcranial direct current stimulation for 20 minutes per day, 5 days a week, at 2mA

Experimental Group

Conventional rehabilitative treatment OTHER

Physiotherapy treatment consisting in two treatments per day of 40 minutes each

Control Group; Experimental Group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• partecipants with a first episode of ischemic or hemorrhagic stroke
• partecipants must be enrolled within 30 days from the stroke

You may not qualify if:

• partecipants with previous episodes of ischemic or hemorrhagic stroke (evaluation by neuroimaging required)
• uncooperative patients
• medically unstable patients
• partecipants with any other neurodegenerative diseases
• epilepsies
• multiple ischemic lesions
• encephalic trunk ischemic lesions

Sponsors & Collaborators

• I.R.C.C.S. Fondazione Santa Lucia: lead

Study Sites (1)

I.R.C.C.S. Fondazione Santa Lucia

Roma, Italy, 00179, Italy

Location

Related Publications (21)

• Allman C, Amadi U, Winkler AM, Wilkins L, Filippini N, Kischka U, Stagg CJ, Johansen-Berg H. Ipsilesional anodal tDCS enhances the functional benefits of rehabilitation in patients after stroke. Sci Transl Med. 2016 Mar 16;8(330):330re1. doi: 10.1126/scitranslmed.aad5651. Epub 2016 Mar 16.

  PMID: 27089207 BACKGROUND

• Barro C, Chitnis T, Weiner HL. Blood neurofilament light: a critical review of its application to neurologic disease. Ann Clin Transl Neurol. 2020 Dec;7(12):2508-2523. doi: 10.1002/acn3.51234. Epub 2020 Nov 4.

  PMID: 33146954 BACKGROUND

• Bikson M, Grossman P, Thomas C, Zannou AL, Jiang J, Adnan T, Mourdoukoutas AP, Kronberg G, Truong D, Boggio P, Brunoni AR, Charvet L, Fregni F, Fritsch B, Gillick B, Hamilton RH, Hampstead BM, Jankord R, Kirton A, Knotkova H, Liebetanz D, Liu A, Loo C, Nitsche MA, Reis J, Richardson JD, Rotenberg A, Turkeltaub PE, Woods AJ. Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Brain Stimul. 2016 Sep-Oct;9(5):641-661. doi: 10.1016/j.brs.2016.06.004. Epub 2016 Jun 15.

  PMID: 27372845 BACKGROUND

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• Bolognini N, Vallar G, Casati C, Latif LA, El-Nazer R, Williams J, Banco E, Macea DD, Tesio L, Chessa C, Fregni F. Neurophysiological and behavioral effects of tDCS combined with constraint-induced movement therapy in poststroke patients. Neurorehabil Neural Repair. 2011 Nov-Dec;25(9):819-29. doi: 10.1177/1545968311411056. Epub 2011 Jul 29.

  PMID: 21803933 BACKGROUND

• Collen FM, Wade DT, Robb GF, Bradshaw CM. The Rivermead Mobility Index: a further development of the Rivermead Motor Assessment. Int Disabil Stud. 1991 Apr-Jun;13(2):50-4. doi: 10.3109/03790799109166684.

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• Di Lazzaro V, Dileone M, Capone F, Pellegrino G, Ranieri F, Musumeci G, Florio L, Di Pino G, Fregni F. Immediate and late modulation of interhemipheric imbalance with bilateral transcranial direct current stimulation in acute stroke. Brain Stimul. 2014 Nov-Dec;7(6):841-8. doi: 10.1016/j.brs.2014.10.001. Epub 2014 Oct 13.

  PMID: 25458712 BACKGROUND

• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

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• Gattringer T, Pinter D, Enzinger C, Seifert-Held T, Kneihsl M, Fandler S, Pichler A, Barro C, Grobke S, Voortman M, Pirpamer L, Hofer E, Ropele S, Schmidt R, Kuhle J, Fazekas F, Khalil M. Serum neurofilament light is sensitive to active cerebral small vessel disease. Neurology. 2017 Nov 14;89(20):2108-2114. doi: 10.1212/WNL.0000000000004645. Epub 2017 Oct 18.

  PMID: 29046363 BACKGROUND

• Gentil BJ, Tibshirani M, Durham HD. Neurofilament dynamics and involvement in neurological disorders. Cell Tissue Res. 2015 Jun;360(3):609-20. doi: 10.1007/s00441-014-2082-7. Epub 2015 Jan 8.

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• Khalil M, Teunissen CE, Otto M, Piehl F, Sormani MP, Gattringer T, Barro C, Kappos L, Comabella M, Fazekas F, Petzold A, Blennow K, Zetterberg H, Kuhle J. Neurofilaments as biomarkers in neurological disorders. Nat Rev Neurol. 2018 Oct;14(10):577-589. doi: 10.1038/s41582-018-0058-z.

  PMID: 30171200 BACKGROUND

• Khedr EM, Shawky OA, El-Hammady DH, Rothwell JC, Darwish ES, Mostafa OM, Tohamy AM. Effect of anodal versus cathodal transcranial direct current stimulation on stroke rehabilitation: a pilot randomized controlled trial. Neurorehabil Neural Repair. 2013 Sep;27(7):592-601. doi: 10.1177/1545968313484808. Epub 2013 Apr 22.

  PMID: 23609526 BACKGROUND

• MAHONEY FI, BARTHEL DW. FUNCTIONAL EVALUATION: THE BARTHEL INDEX. Md State Med J. 1965 Feb;14:61-5. No abstract available.

  PMID: 14258950 BACKGROUND

• Sattler V, Acket B, Raposo N, Albucher JF, Thalamas C, Loubinoux I, Chollet F, Simonetta-Moreau M. Anodal tDCS Combined With Radial Nerve Stimulation Promotes Hand Motor Recovery in the Acute Phase After Ischemic Stroke. Neurorehabil Neural Repair. 2015 Sep;29(8):743-54. doi: 10.1177/1545968314565465. Epub 2015 Jan 7.

  PMID: 25567120 BACKGROUND

• Ziemann U, Paulus W, Nitsche MA, Pascual-Leone A, Byblow WD, Berardelli A, Siebner HR, Classen J, Cohen LG, Rothwell JC. Consensus: Motor cortex plasticity protocols. Brain Stimul. 2008 Jul;1(3):164-82. doi: 10.1016/j.brs.2008.06.006. Epub 2008 Jul 1.

  PMID: 20633383 BACKGROUND

• Gladstone DJ, Danells CJ, Black SE. The fugl-meyer assessment of motor recovery after stroke: a critical review of its measurement properties. Neurorehabil Neural Repair. 2002 Sep;16(3):232-40. doi: 10.1177/154596802401105171.

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• Rech KD, Salazar AP, Marchese RR, Schifino G, Cimolin V, Pagnussat AS. Fugl-Meyer Assessment Scores Are Related With Kinematic Measures in People with Chronic Hemiparesis after Stroke. J Stroke Cerebrovasc Dis. 2020 Jan;29(1):104463. doi: 10.1016/j.jstrokecerebrovasdis.2019.104463. Epub 2019 Nov 15.

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• Park GT, Kim M. Correlation between mobility assessed by the Modified Rivermead Mobility Index and physical function in stroke patients. J Phys Ther Sci. 2016 Aug;28(8):2389-92. doi: 10.1589/jpts.28.2389. Epub 2016 Aug 31.

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  PMID: 35948869 BACKGROUND

MeSH Terms

Conditions

Stroke; Charcot-Marie-Tooth disease, Type 1F

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Stefano Brunelli, MD

  I.R.C.C.S. Fondazione Santa Lucia, Roma, Italy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Physiatrist of the Operative Unit 4 for inpatient rehabilitation

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: April 20, 2023
• Study Start: March 2, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: March 13, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: Beginning 3 months and ending 5 years following article publication
• Access Criteria: Proposals should be directed to the personal corrisponding author's mail address.

Locations

IT (1)