Primary Cervical Dystonia
Conditions
Brief 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.
Detailed 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
Interventions
DEVICEtranscranial 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
University of Colorado, Denver
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase I: A change in brain functional connectivity in primary cervical dystonia | Day 1 | A change in mean functional connectivity between the pallidum and putamen during a resting state in CD patients during inhibitory tACS targeting the sensorimotor network. |
| Phase II: Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score | Day 1, Day 5 | A change in TWSTRS scores following five daily sessions of inhibitory tACS. |
Countries
United States
Outcome results
None listed