CompletedNot Applicable

Transcranial Electrical Stimulation for Cervical Dystonia

United States36 participantsStarted 2017-10-27

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Phase I: A change in brain functional connectivity in primary cervical dystonia

Timeframe: Day 1

Phase II: Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score

Timeframe: Day 1, Day 5

Trial details

NCT IDNCT03369613

SponsorUniversity of Colorado, Denver

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09-20

View on ClinicalTrials.gov More Primary Cervical Dystonia trials