Anxiety & Depression Association of America

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	Device: Transcranial Direct Current Stimulation Transcranial direct current stimulation (tDCS) is a commonly used non-invasive form of brain stimulation for studying motor functions in health and disease [36]. It involves the attachment of surface electrodes to the scalp through which very small electric currents (1 or 2mA) are applied via a current regulated device. The currents do not produce any sensation. The applied current affects excitability of underlying neural tissue. Other names: tDCS Brain Stimulation Neuromodulation
Experimental Active tDCS	Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA	Device: Transcranial Direct Current Stimulation Transcranial direct current stimulation (tDCS) is a commonly used non-invasive form of brain stimulation for studying motor functions in health and disease [36]. It involves the attachment of surface electrodes to the scalp through which very small electric currents (1 or 2mA) are applied via a current regulated device. The currents do not produce any sensation. The applied current affects excitability of underlying neural tissue. Other names: tDCS Brain Stimulation Neuromodulation

Recruiting Locations

More Details

Status: Recruiting
Sponsor: Johns Hopkins University

Study Contact

Yousef Salimpour, Ph.D.
410-502-2666
ysalimp1@jhmi.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.