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

Not Applicable

Suspended

• Conditions: Parkinson Disease; Idiopathic Parkinson's Disease; Depression
• Interventions: Device: Transcranial Direct Current Stimulation

• Registration Number: NCT03074812
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-02
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-09
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2026-02-28
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham tDCS	Transcranial Direct Current Stimulation	Sham transcranial direct current stimulation where current will be reduced to zero after standardized ramp up to 2 mA
Active tDCS	Transcranial Direct Current Stimulation	Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA

Primary Outcome Measures

Name	Time	Method
Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview	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 Outcome Measures

Name	Time	Method
Performance on abbreviated cognitive battery	1 month	Objective improvement on measures of attention, verbal fluency, working memory and recall by various bedside cognitive tests
Subjective improvement of Anxiety Symptoms via Rating Scale	1 month	The change in Parkinson Anxiety Scale (PAS) score per person and across sham v. experimental groups.
Subjective Depression Severity rated via self-report on depression inventory	1 months	Subjective severity of depression as measured via self-reported Beck Depression Inventory - II
Apathy Scores as measure by a self-report scale (the Apathy Scale)	1 months	The dimensional degree of change in Apathy symptoms as assessed via the Apathy Scale, a subjective self-report tool of apathetic symptoms
Subjective reactive to pleasure (i.e. improvement of anhedonia) as rated via self-report	1 month	Monitoring degree of change of hedonic-tone scores via the Snaith-Hamilton Pleasure Scale (SHAPS)
Improvement of Parkinsonian Motor Symptoms	1 month	Number of participants between arms and individual improvement of Movement Disorders Society Unified Parkinson Disease Rating Scale Part 3 (MDS-UPDRS Pt3) Score.

Trial Locations

Locations (1)

Johns Hopkins Hospital / Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States