Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct… (NCT03074812) | Clinical Trial Compass
SuspendedNot Applicable
Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation
Stopped: Lack of funding and did not complete enrollment.
United States80 participantsStarted 2016-02
Plain-language 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.
Who can participate
Age range
18 Years – 95 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 s…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview