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

Primary Purpose

Idiopathic Parkinson's Disease, Parkinson Disease, Depression

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Parkinson's Disease

Eligibility Criteria

18 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Johns Hopkins Hospital / Johns Hopkins UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham tDCS

Active tDCS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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
Subjective Depression Severity rated via self-report on depression inventory
Subjective severity of depression as measured via self-reported Beck Depression Inventory - II
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)
Subjective improvement of Anxiety Symptoms via Rating Scale
The change in Parkinson Anxiety Scale (PAS) score per person and across sham v. experimental groups.
Performance on abbreviated cognitive battery
Objective improvement on measures of attention, verbal fluency, working memory and recall by various bedside cognitive tests
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.

Full Information

First Posted
March 2, 2016
Last Updated
March 29, 2023
Sponsor
Johns Hopkins University
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1. Study Identification

Unique Protocol Identification Number
NCT03074812
Brief Title
Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation
Official Title
Exploring Mechanisms for Neuropsychiatric Symptoms of Parkinson Disease Using Transcranial Direct Current Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2016 (undefined)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Parkinson's Disease, Parkinson Disease, Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Sham transcranial direct current stimulation where current will be reduced to zero after standardized ramp up to 2 mA
Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation according to protocol maintained for 30 minutes after ramping up to 2 mA
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation
Other Intervention Name(s)
tDCS, Brain Stimulation, Neuromodulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants Demonstrating improvements on Objective Rating Scales of Depression via structured interview
Description
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)
Time Frame
1 months
Secondary Outcome Measure Information:
Title
Apathy Scores as measure by a self-report scale (the Apathy Scale)
Description
The dimensional degree of change in Apathy symptoms as assessed via the Apathy Scale, a subjective self-report tool of apathetic symptoms
Time Frame
1 months
Title
Subjective Depression Severity rated via self-report on depression inventory
Description
Subjective severity of depression as measured via self-reported Beck Depression Inventory - II
Time Frame
1 months
Title
Subjective reactive to pleasure (i.e. improvement of anhedonia) as rated via self-report
Description
Monitoring degree of change of hedonic-tone scores via the Snaith-Hamilton Pleasure Scale (SHAPS)
Time Frame
1 month
Title
Subjective improvement of Anxiety Symptoms via Rating Scale
Description
The change in Parkinson Anxiety Scale (PAS) score per person and across sham v. experimental groups.
Time Frame
1 month
Title
Performance on abbreviated cognitive battery
Description
Objective improvement on measures of attention, verbal fluency, working memory and recall by various bedside cognitive tests
Time Frame
1 month
Title
Improvement of Parkinsonian Motor Symptoms
Description
Number of participants between arms and individual improvement of Movement Disorders Society Unified Parkinson Disease Rating Scale Part 3 (MDS-UPDRS Pt3) Score.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yousef Salimpour, Ph.D.
Phone
410-502-2666
Email
ysalimp1@jhmi.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kelly Mills, M.D.
Phone
410-502-0133
Ext
4
Email
kmills16@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kelly Mills, M.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Hospital / Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yousef Salimpour, Ph.D.
Phone
410-502-2666
Email
ysalimp1@jhmi.edu
First Name & Middle Initial & Last Name & Degree
Kelly Mills, M.D.
Phone
410-502-0133
Ext
4
Email
kmills16@jhmi.edu

12. IPD Sharing Statement

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

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