Transcranial Electrical Stimulation for Cervical Dystonia

April 21, 2022 updated by: University of Colorado, Denver

Transcranial Electrical Stimulation (tES) for the Treatment of Cervical Dystonia

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: MRI - HC tDCS
Healthy controls in Phase 1 transcranial electrical stimulation set to direct current
Device: 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.
Active Comparator: MRI - HC tACS
Healthy controls in Phase 1- transcranial electrical stimulation set to alternating current
Device: 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.
Active Comparator: MRI - CD tCDS
Cervical dystonia in Phase 1 transcranial electrical stimulation set to direct current
Device: 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.
Active Comparator: MRI - CD tACS
Cervical dystonia in Phase 1 transcranial electrical stimulation set to alternating current
Device: 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.
Active Comparator: Phase II - Stim
Cervical dystonia in Phase 2 transcranial electrical stimulation setting is active
Device: 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.
Sham Comparator: Phase II - Sham
Cervical dystonia in Phase 2 transcranial electrical stimulation setting is sham
Device: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase I: A change in brain functional connectivity in primary cervical dystonia
Time Frame: 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.
Day 1
Phase II: Improvement in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) score
Time Frame: Day 1, Day 5
A change in TWSTRS scores following five daily sessions of inhibitory tACS.
Day 1, Day 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Colorado, Denver

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Brian Berman, MD, University of Colorado, Denver

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 20, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 20, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 29, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 8, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 21, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-1322

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Primary Cervical Dystonia

Clinical Trials on transcranial electrical stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings