Transcranial Electrical Stimulation for Cervical Dystonia
Status
Conditions
Treatments
Details and patient eligibility
About
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.
Full description
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
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
36 participants in 6 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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