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

Not Applicable

Recruiting

• Conditions: Parkinson Disease

• Registration Number: NCT06804668
• Lead Sponsor: Brigham and Women's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-01-22
• Study First Submitted QC: 2025-01-27
• Study First Posted: 2025-02-03
• Study Start: 2025-02-06
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-04
• Last Update Posted: 2025-03-05
• Primary Completion: 2025-07-31
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of repeated network-targeted multifocal tDCS at home	8 days.	Measures the total number of days each participant successfully completes tDCS sessions at home, aiming for seven consecutive days.; Method: Daily online logs.

Secondary Outcome Measures

Name	Time	Method
Safety of repeated network-targeted multifocal tDCS at home	8 days.	Counts adverse events related to tDCS or technical difficulties over the 8-day period.
Questionnaires for difficulty in usability, subjective effect on motor symptoms, severity of side effects	8 days.	Visual analogue scales (VAS, 0-10) will be performed daily. 0 is the minimum and 10 the maximum score.
Motor outcome	8 days.	Outcome in MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). This score is specifically designed to assess the motor symptoms of Parkinson's disease.; Scoring Range: * Minimum Score: 0 (No motor impairment); * Maximum Score: 132 (Severe motor impairment)

Trial Locations

Locations (1)

Center for Brain Circuit Therapeutics, Department of Neurology, Brigham & Women's Hospital; 🇺🇸 Boston, Massachusetts, United States