Parkinson Disease
Conditions
Keywords
Brain stimulation, Parkinson, Movement disorder, Non-invasive brain stimulation
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.
Interventions
DEVICEtDCS
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.
Sponsors
Brigham and Women's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Masking description
Scores will be recorded on video to ensure blinding to the timepoint of clinical scores.
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMichael D Fox, MD, PhD
Center for Brain Circuit Therapeutics, Department of Neurology, Brigham & Women's Hospital, Boston, MA
Outcome results
None listed