Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active tDCS | Experimental | Subjects receiving active tDCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of repeated network-targeted multifocal tDCS at home | Counts adverse events related to tDCS or technical difficulties over the 8-day period. | 8 days. |
| Questionnaires for difficulty in usability, subjective effect on motor symptoms, severity of side effects |
| Measure | Description | Time Frame |
|---|---|---|
| Support | Open point: level and amount of support needed. | 8 days. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Michael D Fox, MD, PhD | Center for Brain Circuit Therapeutics, Department of Neurology, Brigham & Women's Hospital, Boston, MA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Brain Circuit Therapeutics, Department of Neurology, Brigham & Women's Hospital | Boston | Massachusetts | 02115 | United States |
We plan to share individual participant data collected during the study after de-identification (removal of personal identifiers).
Data to be Shared:
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D009069 | Movement Disorders |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
Not provided
Not provided
Not provided
Not provided
Not provided
Scores will be recorded on video to ensure blinding to the timepoint of clinical scores.
Not provided
|
Visual analogue scales (VAS, 0-10) will be performed daily. 0 is the minimum and 10 the maximum score. |
| 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:
| 8 days. |
| D009422 | Nervous System Diseases |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |