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Completed

NCT Number: NCT06804668

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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of repeated network-targeted multifocal tDCS at home

    Time frame: 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 outcomes

  1. Safety of repeated network-targeted multifocal tDCS at home

    Time frame: 8 days.

    Counts adverse events related to tDCS or technical difficulties over the 8-day period.

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

    Time frame: 8 days.

    Visual analogue scales (VAS, 0-10) will be performed daily. 0 is the minimum and 10 the maximum score.

  3. Motor outcome

    Time frame: 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)

Other outcomes

  1. Support

    Time frame: 8 days.

    Open point: level and amount of support needed.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Acronym: Home-PD-tDCS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 3, 2025
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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