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

NCT06804668 | Recruiting FDA Device

• 1 other identifier: 2024P001978
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Brain stimulation; Parkinson; Movement disorder; Non-invasive brain stimulation

Outcome Measures

Primary Outcomes (1)

• Feasibility of repeated network-targeted multifocal tDCS at home

  Measures the total number of days each participant successfully completes tDCS sessions at home, aiming for seven consecutive days. Method: Daily online logs.

  8 days.

Secondary Outcomes (3)

• Safety of repeated network-targeted multifocal tDCS at home

  8 days.

• Questionnaires for difficulty in usability, subjective effect on motor symptoms, severity of side effects

  8 days.

• Motor outcome

  8 days.

Other Outcomes (1)

• Support

  8 days.

Study Arms (1)

Active tDCS

EXPERIMENTAL

Subjects receiving active tDCS

Device: tDCS

Interventions

tDCS DEVICE

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.

Active tDCS

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

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

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Movement Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Michael D Fox, MD, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Leila Montaser Kouhsari, MD, PhD

CONTACT

(617) 732-7547; lmontaser@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Scores will be recorded on video to ensure blinding to the timepoint of clinical scores.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Brain Circuit Therapeutics

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 3, 2025
• Study Start: February 6, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)