Parkinson DiseaseHome-PD-tDCSNCT06804668
Safety and Feasibility of Tele-supervised Home-based Transcranial Direct Current Stimulation in Parkinson's Disease
A study testing tDCS in people with Parkinson Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2025to 12 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Brain Circuit Therapeutics, Department of Neurology, Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
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
- Being tested
- tDCS
- Keywords
- Brain stimulation, Parkinson, Movement disorder, Non-invasive brain stimulation
- Medical subject headings
- Parkinson Disease, Movement Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active tDCS | Experimental | Subjects receiving active tDCS Receives: Device: tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 days.
Secondary outcomes (3)
Safety of repeated network-targeted multifocal tDCS at home
Counts adverse events related to tDCS or technical difficulties over the 8-day period.
Measured: 8 days.
Questionnaires for difficulty in usability, subjective effect on motor symptoms, severity of side effects
Visual analogue scales (VAS, 0-10) will be performed daily. 0 is the minimum and 10 the maximum score.
Measured: 8 days.
Motor outcome
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)
Measured: 8 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start6 Feb 2025
- Primary completion12 Feb 2026
- Study completion12 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael D. Fox, M.D.,Ph.D., Brigham and Women's Hospital
- Investigators
- Michael D Fox, MD, PhD, Principal investigator, Center for Brain Circuit Therapeutics, Department of Neurology, Brigham & Women's Hospital, Boston, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06804668
- Sponsor's protocol ID
- 2024P001978
- Acronym
- Home-PD-tDCS
- Status last verified
- May 2026
- First submitted
- 22 Jan 2025
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: We plan to share individual participant data collected during the study after de-identification (removal of personal identifiers). Data to be Shared: * De-identified individual participant data, including: * Demographic information (age range, gender) * Clinical assessments such as MDS-UPDRS-III scores * Responses to usability and side effect questionnaires * Information on any reported adverse events
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Feasibility of Tele-supervised Home-based Transcranial Direct Current Stimulation in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06804668
- Acronym / sponsor ID
- Home-PD-tDCS / 2024P001978
- Conditions
- Parkinson Disease
- Keywords
- Brain stimulation, Parkinson, Movement disorder, Non-invasive brain stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 6 Feb 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2026 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active tDCS | Experimental | Device: tDCSSubjects receiving active tDCS |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- Psychiatric symptoms such as moderate or severe depression
- Cranial metal implants
- Cardiac pacemaker
- Epilepsy, stroke
- Substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tDCSThe 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. | Device | Active tDCS |
Primary outcome
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.
3 secondary outcomes
Safety of repeated network-targeted multifocal tDCS at home
Time frame: 8 days.
Questionnaires for difficulty in usability, subjective effect on motor symptoms, severity of side effects
Time frame: 8 days.
Motor outcome
Time frame: 8 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. We plan to share individual participant data collected during the study after de-identification (removal of personal identifiers). Data to be Shared: * De-identified individual participant data, including: * Demographic information (age range, gender) * Clinical assessments such as MDS-UPDRS-III scores * Responses to usability and side effect questionnaires * Information on any reported adverse events
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D Fox, MD, PhD principal investigator
Center for Brain Circuit Therapeutics, Department of Neurology, Brigham & Women's Hospital, Boston, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tDCS in people with Parkinson Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of repeated network-targeted multifocal tDCS at home (time frame: 8 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.