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

Sponsor
Johns Hopkins University (Other)
Overall Status
Recruiting
CT.gov ID
NCT03074812
Collaborator
(none)
80
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2
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Direct Current Stimulation
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation
Study Start Date :
Feb 1, 2016
Anticipated Primary Completion Date :
Mar 31, 2023
Anticipated Study Completion Date :
Mar 31, 2023

Arms and Interventions

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:
  • 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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

    2. 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

    3. 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)

    4. 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.

    5. Performance on abbreviated cognitive battery [1 month]

      Objective improvement on measures of attention, verbal fluency, working memory and recall by various bedside cognitive tests

    6. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 95 Years
    Sexes Eligible for Study:
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Johns Hopkins Hospital / Johns Hopkins University Baltimore Maryland United States 21287

    Sponsors and Collaborators

    • Johns Hopkins University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Johns Hopkins University
    ClinicalTrials.gov Identifier:
    NCT03074812
    Other Study ID Numbers:
    • IRB00087957
    First Posted:
    Mar 9, 2017
    Last Update Posted:
    Mar 31, 2022
    Last Verified:
    Mar 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 31, 2022