Back to resultsOpen Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease
Eligibility Criteria
Inclusion Criteria:
- Parkinson's disease or a related disorder (e.g. Multiple Systems Atrophy) as diagnosed by a neurologist specializing in Movement Disorders
- Age >= 18 years
Exclusion Criteria:
- Skull defect at or near site of tDCS delivery.
- History of a significant stroke or traumatic brain injury.
- History of other brain conditions that could impact interpretation of results (such as MS, brain tumor, encephalitis).
- Presence of implanted electrical or metallic devices in the head or body (examples include cardiac pacemakers or defibrillators, Baclofen pumps, deep brain stimulators, ventricular shunts with metallic parts, vagus nerve stimulators)
- Presence of ferrous metal in the head (except titanium; for instance shrapnel)
- History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common antidepressants)
- Pregnancy
Sites / Locations
- MedStar Georgetown University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tDCS
Arm Description
tDCS will be applied with a Soterix CT tDCS Device with a HD-tDCS 4x1 Multi-Channel Stimulation Interface. During stimulation, a low level of constant DC electrical current (1-2 mA) will be applied via the electrodes. Current will be ramped up over 10-60 seconds, and typically causes very mild tingling and itching sensations. The current will be applied for no more than 20 minutes per session, at which time the current is ramped down over 10-60 seconds. Subjects will be seated in a chair throughout tDCS administration. Subjects will receive tDCS 5 days/week for 4 weeks.
Outcomes
Primary Outcome Measures
Improvement of Motor and Speech Symptoms of Parkinson's Disease or Related Disorders
We will perform an assessment of motor function using Part III of the Unified Parkinson's Disease Rating Scale (UPDRS), timed test of gait, and patient self-assessment. Speech functions will be assessed with sentence repetition,evaluation of spontaneous speech, and other standard language tests. The assessment will also include other measures and questionnaires (e.g. Bech Depression Inventory) to be filled out by the patient and his/her family.
Secondary Outcome Measures
Improvement of Neuropsychiatric Symptoms of Parkinson's Disease or Related Disorders
Full Information
NCT ID
NCT02104401
First Posted
April 2, 2014
Last Updated
August 19, 2014
Sponsor
Georgetown University
Collaborators
Ferrell Family Charitable Foundation
1. Study Identification
Unique Protocol Identification Number
NCT02104401
Brief Title
Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood
Official Title
Pilot Study: Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood
Study Type
Interventional
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Georgetown University
Collaborators
Ferrell Family Charitable Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research will help us to understand whether transcranial direct current stimulation (tDCS) can safely improve recovery of speech and language abilities, gait , and mood in people with Parkinson's disease and related disorders. Some of the disorders that will be studied to understand if tDCS can be useful include Parkinson's Disease, Multi-System Atrophy (MSA) and progressive supranuclear palsy (PSP).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
tDCS
Arm Type
Experimental
Arm Description
tDCS will be applied with a Soterix CT tDCS Device with a HD-tDCS 4x1 Multi-Channel Stimulation Interface. During stimulation, a low level of constant DC electrical current (1-2 mA) will be applied via the electrodes. Current will be ramped up over 10-60 seconds, and typically causes very mild tingling and itching sensations. The current will be applied for no more than 20 minutes per session, at which time the current is ramped down over 10-60 seconds. Subjects will be seated in a chair throughout tDCS administration. Subjects will receive tDCS 5 days/week for 4 weeks.
Intervention Type
Device
Intervention Name(s)
tDCS
Intervention Description
tDCS will be applied with a Soterix CT tDCS Device with a HD-tDCS 4x1 Multi-Channel Stimulation Interface. During stimulation, a low level of constant DC electrical current (1-2 mA) will be applied via the electrodes. Current will be ramped up over 10-60 seconds, and typically causes very mild tingling and itching sensations. The current will be applied for no more than 20 minutes per session, at which time the current is ramped down over 10-60 seconds. Subjects will be seated in a chair throughout tDCS administration. Subjects will receive tDCS 5 days/week for 4 weeks.
Primary Outcome Measure Information:
Title
Improvement of Motor and Speech Symptoms of Parkinson's Disease or Related Disorders
Description
We will perform an assessment of motor function using Part III of the Unified Parkinson's Disease Rating Scale (UPDRS), timed test of gait, and patient self-assessment. Speech functions will be assessed with sentence repetition,evaluation of spontaneous speech, and other standard language tests. The assessment will also include other measures and questionnaires (e.g. Bech Depression Inventory) to be filled out by the patient and his/her family.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Improvement of Neuropsychiatric Symptoms of Parkinson's Disease or Related Disorders
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Parkinson's disease or a related disorder (e.g. Multiple Systems Atrophy) as diagnosed by a neurologist specializing in Movement Disorders
Age >= 18 years
Exclusion Criteria:
Skull defect at or near site of tDCS delivery.
History of a significant stroke or traumatic brain injury.
History of other brain conditions that could impact interpretation of results (such as MS, brain tumor, encephalitis).
Presence of implanted electrical or metallic devices in the head or body (examples include cardiac pacemakers or defibrillators, Baclofen pumps, deep brain stimulators, ventricular shunts with metallic parts, vagus nerve stimulators)
Presence of ferrous metal in the head (except titanium; for instance shrapnel)
History of psychiatric disease requiring hospitalization, electroconvulsive therapy, or ongoing medication use (other than common antidepressants)
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Pagan, MD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood
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