Transcranial Electrical Stimulation for Cervical Dystonia

University of Colorado, Denver36 enrolled

Overview

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: 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Primary Cervical Dystonia

Interventions

transcranial electrical stimulationDEVICE

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

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

University of Colorado Denver

Aurora, Colorado, United States

Outcomes

Primary Outcomes

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

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.

Time frame: Day 1

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

A change in TWSTRS scores following five daily sessions of inhibitory tACS.

Time frame: Day 1, Day 5

Data from ClinicalTrials.gov

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