Transcranial Electrical Stimulation for Cervical Dystonia



Status:Recruiting
Conditions:Neurology, Orthopedic
Therapuetic Areas:Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:12/29/2018
Start Date:October 27, 2017
End Date:December 2019
Contact:Erika Shelton
Email:erika.shelton@ucdenver.edu
Phone:303-724-5865

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Transcranial Electrical Stimulation (tES) for the Treatment of Cervical Dystonia

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.

Phase I:

Enrolls both CD patients and healthy controls.

One approximately 3 hour visit which includes:

- a screening & neurological exam,

- clinical scales & questionnaires,

- a (approx.) 60 min MRI scan with simultaneous tES/sham tES in a randomized block design
and EMG

Phase II:

Enrolls only CD patients.

Five consecutive days of study visits.

Day 1:

- TMS screening,

- repeated neurological assessment and clinical scales if >1 month since MRI visit

- 30 min TMS session with concurrent EMG

- 20 min tES or sham tES session

Days 2-4:

- 20 min tES or sham tES session

Day 5:

- 20 min tES or sham tES session

- 30 min TMS session with concurrent EMG

- repeated neurological assessment and clinical scales

Primary Cervical Dystonia

Inclusion Criteria:

- Right-handed

- On a stable dose of all medications used to treat dystonia for the month previous to
enrollment

- No botox injections in the 10 weeks previous to enrollment

Exclusion Criteria:

- Any contraindication to MRI scanning, tES, or TMS (e.g pregnancy, history of seizures,
significant systemic medical conditions, untreated psychiatric or neurological
conditions)

- Evidence on neurological exam of any potentially confounding neurological disorder

- Evidence of significant cognitive impairment

- Patients with dystonia symptoms beginning prior to the age of 18 will be excluded

- Patients with secondary dystonia resulting from medications or that are part of
another neurological disorder (e.g. Parkinson's disease) will be excluded

- Medication that might predispose the subject to seizures

Healthy Controls

Inclusion Criteria:

- Right-handed

Exclusion Criteria:

- Any contraindication to MRI scanning, tES, or TMS (e.g pregnancy, history of seizures,
significant systemic medical conditions, untreated psychiatric or neurological
conditions)

- Evidence on neurological exam of any potentially confounding neurological disorder

- Evidence of significant cognitive impairment

- Medication that might predispose the subject to seizures
We found this trial at
1
site
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Brian Berman, MD, MS
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Aurora, CO
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