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CompletedNCT03369613Updated Apr 25, 2022

Transcranial Electrical Stimulation for Cervical Dystonia

An interventional study of transcranial electrical stimulation in Primary Cervical Dystonia, sponsored by University of Colorado, Denver. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-25.

Sponsored by University of Colorado, Denver · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was Sep 2021, 5 years 1 month ago, and no results have been posted to the registry.

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Phase
Not applicable
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Primary Cervical Dystonia
03

In context

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,543 studies on the registry; 317 are open to participants now.

Of its 147 completed or terminated interventional studies of FDA-regulated products, 92 (63%) have results posted.

Browse University of Colorado, Denver studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Eligibility 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 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    MRI - HC tDCS

    Healthy controls in Phase 1 transcranial electrical stimulation set to direct current

    Device: transcranial electrical stimulation

  • Active comparator
    MRI - HC tACS

    Healthy controls in Phase 1- transcranial electrical stimulation set to alternating current

    Device: transcranial electrical stimulation

  • Active comparator
    MRI - CD tCDS

    Cervical dystonia in Phase 1 transcranial electrical stimulation set to direct current

    Device: transcranial electrical stimulation

  • Active comparator
    MRI - CD tACS

    Cervical dystonia in Phase 1 transcranial electrical stimulation set to alternating current

    Device: transcranial electrical stimulation

  • Active comparator
    Phase II - Stim

    Cervical dystonia in Phase 2 transcranial electrical stimulation setting is active

    Device: transcranial electrical stimulation

  • Sham comparator
    Phase II - Sham

    Cervical dystonia in Phase 2 transcranial electrical stimulation setting is sham

    Device: transcranial electrical stimulation

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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

07

Study locations

1 site
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Oct 2017 to primary completion in Sep 2021, 46 months.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2017
First posted
Dec 12, 2017
StartActual
Oct 27, 2017
Primary completionActual
Sep 20, 2021
CompletionActual
Sep 20, 2021
Last update
Apr 25, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03369613
Lead sponsor
University of Colorado, Denver
Responsible party
Sponsor
First posted
Dec 12, 2017
Start date
Oct 27, 2017
Primary completion
Sep 20, 2021
Completion
Sep 20, 2021
Last update
Apr 25, 2022

Study contacts

Brian Berman, MD
principal investigator · University of Colorado, Denver

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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