Trials Today

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

Arm	Description	Assigned 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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.