Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation
Purpose
This study evaluates the effect of transcranial direct current stimulation (tDCS) on non-motor symptoms of Parkinson's disease, including depression and cognitive symptoms. Participants are randomized to receive active or sham tDCS for 30 minutes over 10 treatment sessions.
Conditions
- Idiopathic Parkinson's Disease
- Parkinson Disease
- Depression
Eligibility
- Eligible Ages
- Between 18 Years and 95 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Abel to provide written informed consent is obtained in the English language - Age 18 to 95 years old - Movement Disorder Society Clinical Diagnostic Criteria for probable idiopathic Parkinson disease - Report disabling depressive or neuropsychiatric symptoms prior to study entry - Capacity to understand the nature of the study;
Exclusion Criteria
- Known structural brain disease such as a neoplasm, abscess etc. - Pre-existing skull / scalp defects that would impede standardized electrode placement - Current electronic or metal implants - Diagnosis of Bipolar Disorder, Post-Traumatic Stress Disorder, a Psychotic Disorder or any other non-unipolar depressive disorder as a principal diagnosis in the 6 months prior to screening; - Concurrent treatment with medication which may affect tDCS (benzodiazepines, anticonvulsants, dextromethorphan and pseudoephedrine) - Endorse active suicidal ideation at enrollment or during any study visit, or have attempted suicide in the six months prior to screening; - History of substance abuse or dependence in the 2 months prior to screening; - Considered to be at significant risk of committing homicide; - Unstable medical condition; - Score less than 22 on the Montreal Cognitive Assessment (MoCA) - Women of childbearing potential who are pregnant or are considering becoming pregnant during the length of the study; - There has been a change in their depression or psychotherapy treatment regimen in the 2 weeks preceding screening;
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Sham Comparator Sham tDCS |
Sham transcranial direct current stimulation where current will be reduced to zero after standardized ramp up to 2 mA |
|
|
Experimental Active tDCS |
Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA |
|
Recruiting Locations
More Details
- Status
- Recruiting
- Sponsor
- Johns Hopkins University
