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

Phase 1

Completed

• Conditions: Parkinson's Disease
• Interventions: Device: tDCS

• Registration Number: NCT02104401
• Lead Sponsor: Georgetown University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-04
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-19
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tDCS	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.

Primary Outcome Measures

Name	Time	Method
Improvement of Motor and Speech Symptoms of Parkinson's Disease or Related Disorders	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.

Secondary Outcome Measures

Name	Time	Method
Improvement of Neuropsychiatric Symptoms of Parkinson's Disease or Related Disorders	16 weeks

Trial Locations

Locations (1)

MedStar Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States