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 |
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: 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
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
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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