Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood

August 19, 2014 updated by: Georgetown University

Pilot Study: Open Label Treatment With tDCS for Parkinson's and Related Disorders for Improvement of Speech, Gait and Mood

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • MedStar Georgetown University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS
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.
Device: tDCS
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of Motor and Speech Symptoms of Parkinson's Disease or Related Disorders
Time Frame: 16 weeks
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.
16 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement of Neuropsychiatric Symptoms of Parkinson's Disease or Related Disorders
Time Frame: 16 weeks
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

Ferrell Family Charitable Foundation

Investigators

  • Principal Investigator: Fernando Pagan, MD, Georgetown University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2014

Study Registration Dates

First Submitted

April 2, 2014

First Submitted That Met QC Criteria

April 2, 2014

First Posted (Estimate)

April 4, 2014

Study Record Updates

Last Update Posted (Estimate)

August 20, 2014

Last Update Submitted That Met QC Criteria

August 19, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00000

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Parkinson's Disease

Clinical Trials on tDCS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guatemala

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe