Transcranial Electrical Stimulation for Cervical Dystonia
NCT03369613 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36
Last updated 2022-04-25
Summary
There are two phases.
Phase I: A single visit which includes a screening, clinical scales, and a MRI scan with simultaneous tES/sham tES in a randomized block design. Enrolls both Cervical Dystonia (CD) patients and healthy controls.
Phase II: 5 consecutive days of 30-90 min visits to campus for tES or sham tES. Transcranial magnetic stimulation (TMS) measures and clinical scales will also be included on Day 1 and Day 5 visits. Enrolls only CD patients.
Conditions
- Primary Cervical Dystonia
Interventions
- DEVICE
-
transcranial electrical stimulation
The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.
Sponsors & Collaborators
-
University of Colorado, Denver
lead OTHER
Principal Investigators
-
Brian Berman, MD · University of Colorado, Denver
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2017-10-27
- Primary Completion
- 2021-09-20
- Completion
- 2021-09-20
- FDA Device
- Yes
Countries
- United States
Study Locations
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