Transcranial Electrical Stimulation for Cervical Dystonia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-27

Study Completion Date

2021-09-20

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Primary Cervical Dystonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Intervention Type DEVICE

The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.

Interventions

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transcranial electrical stimulation

The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.

Intervention Type DEVICE

Eligibility Criteria

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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

\- 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
* 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

* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes