Low Voltage Electrical Stimulation for Depression in Parkinson's Patients

NCT06467695 | Not Yet Recruiting DMC

• 1 other identifier: 2128181
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to determine the relative efficacy of fMRI model guided Transcranial Direct Current Stimulation (mgTDCS) in improving the depressive symptoms of patients with Parkinson's Disease (PD). The main questions it aims to answer are: 1) Can the use of mgTDCS significantly improve the self-reported level of depression and apathy in patients with PD from pre-intervention to post-intervention compared to a sham control? 2) Can the use of mgTDCS significantly normalize the cortical eeg alpha asymmetry so commonly seen in depressed patients compared to sham mgTDCS? 3) Can the use of mgTDCS significantly improve scores on neuropsychological tests of working memory?

Conditions

Parkinson Disease; Depressive Symptoms

Keywords

Direct Transcranial Current Stimulation

Outcome Measures

Primary Outcomes (3)

• Beck Depression Inventory (BDI) Pre-post change score

  The BDI, a self-report measure for assessing depression, has high internal consistency (Cronbach's alpha \> .90) and good test-retest reliability.

  One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.

• Alpha band power pre-post change score

  Alpha band power from pre-post eeg records will be assessed for power changes at frontal sites.

  One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.

• RBANS Working Memory

  Digit Span and Story Memory subtests will be used to determine changes in working memory.

  One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.

Secondary Outcomes (1)

• PDQ-39

  One at Day 1 and one after 15 sessions of training, typically 4 weeks after study start.

Study Arms (2)

Electrical Stimulation (experimental)

EXPERIMENTAL

Transcranial Direct Current Stimulation will be administered in a high definition anodal montage at 2 milliamps with anode over T3 (adjusted for each participant) and cathode in an equidistance ring around it with 4 return electrodes. There will be 13 minutes of active stimulation followed by a twenty minute delay, followed by 13 minutes of stimulation. Participants in the pilot study will be administered 2 mA of current at a steady state with a 30 second ramp-up and ramp-down period at the beginning and end of each 13 minute stimulation interval.

Device: BIOPAC Stimsola

Sham Stimulation

SHAM COMPARATOR

For the sham TDCS condition, 10 participants will receive receive sham tDCS consisting of 30 seconds of ramp-up and then the amperage will be reduced to 0 for the remainder of the session.

Device: BIOPAC Stimsola Sham (zero amps)

Interventions

BIOPAC Stimsola DEVICE

Transcranial Electrical Stimulator

Electrical Stimulation (experimental)

BIOPAC Stimsola Sham (zero amps) DEVICE

Transcranial Electrical Stimulator set to 0 amps

Sham Stimulation

Eligibility Criteria

• Age: 19 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• to 65 years in age.
• Parkinson's Group must have a physician dx of Parkinson's Disease
• Must meet exhibit elevated levels of depression on the Beck Depression Inventory (scores of 20 or above).
• Must be willing and able to travel of the Psychology Department for EEG and tDCS sessions.
• Participants who have undergone surgery for Deep Brain Stimulation implantation may be enrolled if advised to and monitored by their physician.
• Read and understand spoken English.

You may not qualify if:

• No history of or being treated for epilepsy or other seizure disorders.
• No history of penetrating head wounds or TBI greater than mild TBI.
• No history of atypical Parkinson's

Sponsors & Collaborators

• University of South Alabama: lead

Related Publications (5)

• Del Felice A, Castiglia L, Formaggio E, Cattelan M, Scarpa B, Manganotti P, Tenconi E, Masiero S. Personalized transcranial alternating current stimulation (tACS) and physical therapy to treat motor and cognitive symptoms in Parkinson's disease: A randomized cross-over trial. Neuroimage Clin. 2019;22:101768. doi: 10.1016/j.nicl.2019.101768. Epub 2019 Mar 18.

  PMID: 30921609 BACKGROUND

• Brak IV, Filimonova E, Zakhariya O, Khasanov R, Stepanyan I. Transcranial Current Stimulation as a Tool of Neuromodulation of Cognitive Functions in Parkinson's Disease. Front Neurosci. 2022 Jul 12;16:781488. doi: 10.3389/fnins.2022.781488. eCollection 2022.

  PMID: 35903808 BACKGROUND

• Broeder S, Vandendoorent B, Hermans P, Nackaerts E, Verheyden G, Meesen R, de Xivry JO, Nieuwboer A. Transcranial direct current stimulation enhances motor learning in Parkinson's disease: a randomized controlled trial. J Neurol. 2023 Jul;270(7):3442-3450. doi: 10.1007/s00415-023-11669-3. Epub 2023 Mar 23.

  PMID: 36952012 BACKGROUND

• Broeder S, Nackaerts E, Heremans E, Vervoort G, Meesen R, Verheyden G, Nieuwboer A. Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects. Neurosci Biobehav Rev. 2015 Oct;57:105-17. doi: 10.1016/j.neubiorev.2015.08.010. Epub 2015 Aug 20.

  PMID: 26297812 BACKGROUND

• de Oliveira PCA, de Araujo TAB, Machado DGDS, Rodrigues AC, Bikson M, Andrade SM, Okano AH, Simplicio H, Pegado R, Morya E. Transcranial Direct Current Stimulation on Parkinson's Disease: Systematic Review and Meta-Analysis. Front Neurol. 2022 Jan 10;12:794784. doi: 10.3389/fneur.2021.794784. eCollection 2021.

  PMID: 35082749 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Depression

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Study Officials

• John Shelley-Tremblay, PhD

  2514606883

  PRINCIPAL INVESTIGATOR

Central Study Contacts

John F Shelley-Tremblay, PhD

CONTACT

2514606883; jstremblay@southalabama.edu

Benjamin D Hill, PhD

CONTACT

251-460-6546; bdhill@southalabama.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not be told whether they are receiving tDCS or SHAM tDCS in order to reduce subject expectancy bias.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants (n = 40) will be either in the Parkinson's Group (n = 20) or the No Parkinson's Control (N = 20). All patients will be randomly assigned to receive either tDCS or SHAM tDCS.

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: June 21, 2024
• Study Start: August 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: June 21, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share