Clinical trial NCT03074812: Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation
Official title: Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Idiopathic Parkinson's Disease
Parkinson Disease
Depression
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2017-03-09
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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;

Primary outcomes:
measure: Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview
timeFrame: 1 months
Secondary outcomes:
measure: Apathy Scores as measure by a self-report scale (the Apathy Scale)
timeFrame: 1 months
measure: Subjective Depression Severity rated via self-report on depression inventory
timeFrame: 1 months
measure: Subjective reactive to pleasure (i.e. improvement of anhedonia) as rated via self-report
timeFrame: 1 month
measure: Subjective improvement of Anxiety Symptoms via Rating Scale
timeFrame: 1 month
measure: Performance on abbreviated cognitive battery
timeFrame: 1 month
measure: Improvement of Parkinsonian Motor Symptoms
timeFrame: 1 month
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital / Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Kelly Mills, M.D.
role: PRINCIPAL_INVESTIGATOR
References: