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Completed

NCT Number: NCT03369613

Transcranial Electrical Stimulation for 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.

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Key information

Conditions

Primary Cervical Dystonia Cervical Dystonia, Primary

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcranial Electrical Stimulation

Device

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

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Colorado, Denver

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Dec 12, 2017
Registry last updated
Apr 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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