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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression; Parkinson Disease; Idiopathic Parkinson's Disease
• Intervention / Treatment: Device: Transcranial Direct Current Stimulation

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yousef Salimpour, Ph.D.; Phone Number: 410-502-2666; Email: ysalimp1@jhmi.edu
• Study Contact Backup: Name: Kelly Mills, M.D.; Phone Number: 4 410-502-0133; Email: kmills16@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Recruiting
      • Johns Hopkins Hospital / Johns Hopkins University
      • Contact: Yousef Salimpour, Ph.D.; Phone Number: 410-502-2666; Email: ysalimp1@jhmi.edu
      • Contact: Kelly Mills, M.D.; Phone Number: 4 410-502-0133; Email: kmills16@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Neuromodulation; tDCS; Brain Stimulation
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: Neuromodulation; tDCS; Brain Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Kelly Mills, M.D., Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: March 2, 2016
• First Submitted That Met QC Criteria: March 3, 2017
• First Posted (Actual): March 9, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 20, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: IRB00087957