Safety and Feasibility of Tele-supervised Home-based Transcranial Direct Current Stimulation in Parkinson's Disease

Purpose

The goal of this clinical trial is to learn whether home-based transcranial direct current stimulation (tDCS) is safe and practical for people aged 40 to 70 years with Parkinson's Disease. The study aims to find out if participants can use the tDCS device at home without serious side effects and whether it is easy for them to use on their own. Participants will first attend an in-person visit to learn how to use the tDCS device. They will then use the device at home once a day for 20 minutes over seven consecutive days. Video calls on days 2 and 3 will provide support and supervision. After each session, participants will complete brief online questionnaires about any side effects and how easy the device was to use. The study will also check if using tDCS at home improves motor symptoms in Parkinson's Disease by using a standard movement assessment.

Condition

  • Parkinson Disease

Eligibility

Eligible Ages
Between 40 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patients with the diagnosis of Parkinson's disease, aged between 40 and 70, who provide verbal and written informed consent will be included. Patients should have access to a computer system for video calls and completing the questionnaires, and they must be able to use it.

Exclusion Criteria

  • Psychiatric symptoms such as moderate or severe depression - Cranial metal implants - Cardiac pacemaker - Epilepsy, stroke - Substance abuse - Inability to adjust the neoprene cap with the electrodes independently due to movement disturbances

Study Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Device Feasibility
Masking
None (Open Label)
Masking Description
Scores will be recorded on video to ensure blinding to the timepoint of clinical scores.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Active tDCS 		Subjects receiving active tDCS
  • Device: tDCS
    The intervention involves a home-based, self-administered application of network-targeted, multifocal transcranial direct current stimulation (tDCS) using the Neuroelectrics® StarStim Home-tES device. Participants will apply the tDCS for 20 minutes each day over seven consecutive days. The device is specifically programmed to target a brain network associated with motor symptom improvement in Parkinson's Disease, based on recent research identifying this network through deep brain stimulation studies.

Recruiting Locations

Center for Brain Circuit Therapeutics, Department of Neurology, Brigham & Women's Hospital
Boston, Massachusetts 02115
Contact:
Leila Montaser Kouhsari, MD, PhD
617-732-7547
lmontaser@bwh.harvard.edu

More Details

NCT ID
NCT06804668
Status
Recruiting
Sponsor
Brigham and Women's Hospital

Study Contact

Leila Montaser Kouhsari, MD, PhD
(617) 732-7547
lmontaser@bwh.harvard.edu

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center