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NCT06804668 | RECRUITING | Parkinson Disease

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

Brigham and Women's Hospital

Information provided by (Responsible Party):

Michael D. Fox, M.D.,Ph.D.

Brief Summary:

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 or disease

Parkinson Disease

Intervention/treatment

tDCS

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 6 participants
Masking : NONE
Masking Description : Scores will be recorded on video to ensure blinding to the timepoint of clinical scores.
Primary Purpose : DEVICE_FEASIBILITY
Official Title : Safety and Feasibility of Tele-supervised Home-based Transcranial Direct Current Stimulation in Parkinson's Disease
Actual Study Start Date : 2025-02-06
Estimated Primary Completion Date : 2026-07-31
Estimated Study Completion Date : 2026-09-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 40 Years to 70 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Safety and Feasibility of Tele-supervised Home-based Transcranial Direct Current Stimulation in Parkinson's Disease

Location Details

NCT06804668

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Locations

RECRUITING

United States, Massachusetts

Center for Brain Circuit Therapeutics, Department of Neurology, Brigham & Women's Hospital

Boston, Massachusetts, United States, 02115