Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation

NCT03074812 | Suspended

• 1 other identifier: IRB00087957
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Parkinson's Disease; Parkinson Disease; Depression

Outcome Measures

Primary Outcomes (1)

• Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview

  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)

  1 months

Secondary Outcomes (6)

• Apathy Scores as measure by a self-report scale (the Apathy Scale)

  1 months

• Subjective Depression Severity rated via self-report on depression inventory

  1 months

• Subjective reactive to pleasure (i.e. improvement of anhedonia) as rated via self-report

  1 month

• Subjective improvement of Anxiety Symptoms via Rating Scale

  1 month

• Performance on abbreviated cognitive battery

  1 month

Study Arms (2)

Sham tDCS

SHAM COMPARATOR

Sham transcranial direct current stimulation where current will be reduced to zero after standardized ramp up to 2 mA

Device: Transcranial Direct Current Stimulation

Active tDCS

EXPERIMENTAL

Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA

Device: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation DEVICE

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.

Also known as: tDCS, Brain Stimulation, Neuromodulation

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins Hospital / Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Depression

Interventions

Transcranial Direct Current Stimulation; Deep Brain Stimulation; Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Surgical Procedures, Operative; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Kelly Mills, M.D.

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2016
• First Posted: March 9, 2017
• Study Start: February 1, 2016
• Primary Completion (Estimated): February 28, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

US (1)