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

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ClinicalTrials.gov Identifier: NCT03074812
Recruitment Status : Recruiting
First Posted : March 9, 2017
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Idiopathic Parkinson's Disease Parkinson Disease Depression Device: Transcranial Direct Current Stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : February 2016
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 1 month ]
    The change in Parkinson Anxiety Scale (PAS) score per person and across sham v. experimental groups.

  5. Performance on abbreviated cognitive battery [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03074812


Contacts
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Contact: Yousef Salimpour, Ph.D. 410-502-2666 ysalimp1@jhmi.edu
Contact: Kelly Mills, M.D. 410-502-0133 ext 4 kmills16@jhmi.edu

Locations
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United States, Maryland
Johns Hopkins Hospital / Johns Hopkins University Recruiting
Baltimore, Maryland, United States, 21287
Contact: Yousef Salimpour, Ph.D.    410-502-2666    ysalimp1@jhmi.edu   
Contact: Kelly Mills, M.D.    410-502-0133 ext 4    kmills16@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Kelly Mills, M.D. Johns Hopkins University

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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03074812     History of Changes
Other Study ID Numbers: IRB00087957
First Posted: March 9, 2017    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases