Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Suspended
- Sponsor
- Johns Hopkins University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 95 Years (Adult, Older Adult)
- Sex
- 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;
Arms & Interventions
Sham tDCS
Sham transcranial direct current stimulation where current will be reduced to zero after standardized ramp up to 2 mA
Intervention: Transcranial Direct Current Stimulation (Device)
Active tDCS
Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA
Intervention: Transcranial Direct Current Stimulation (Device)
Outcomes
Primary Outcomes
Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview
Time Frame: 1 months
Primary outcome measure will be the number of participants who demonstrate remission of depressive symptoms OR improvement of 50% (i.e. response) on the Montgomery-Asberg Scale of Depression (MADRS)
Secondary Outcomes
- Subjective improvement of Anxiety Symptoms via Rating Scale(1 month)
- Performance on abbreviated cognitive battery(1 month)
- Subjective Depression Severity rated via self-report on depression inventory(1 months)
- Apathy Scores as measure by a self-report scale (the Apathy Scale)(1 months)
- Subjective reactive to pleasure (i.e. improvement of anhedonia) as rated via self-report(1 month)
- Improvement of Parkinsonian Motor Symptoms(1 month)