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tDCS in Cervical Dystonia

NCT02180139 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-10-03

No results posted yet for this study

Summary

Dystonia is a devastating disorder defined by involuntary, sustained muscle contractions or abnormal postures that can affect any part of the body. Cervical dystonia (CD) is the most pervasive form of dystonia affecting 60-90,000 individuals in the United States alone and is characterized by involuntary twisting of the neck. The symptoms of CD are disabling, disfiguring, painful, and have a strongly negative impact on quality of life, including social withdrawal and depression. At present, there is no treatment that has been shown to have long term benefit in CD. Standard of care (SOC) is botulinum toxin, which temporarily paralyzes affected muscles, resulting in reduced muscle spasms. This treatment has many undesirable side effects, variable effectiveness, is expensive, and must be repeated every 3 months throughout the lifespan. Physical therapy based treatments aimed at retraining posture or stretching dystonic muscles are largely ineffective and not typically delivered as a part of standard of care. There is an urgent need for novel and effective therapies. Emerging technologies, specifically non-invasive brain stimulation (NBS), have demonstrated compelling evidence to make a meaningful impact in the lives of people with CD. In this study, individuals with cervical dystonia will be randomly assigned to receive tDCS for 15 minutes daily for 4 days in 1 of 4 stimulation location groups.

Hypothesis 1: One location of stimulation will result in clear benefit with at least 1 standard deviation (SD) improvement in the CDQ-24, the primary outcome measure, at 1-week follow-up.

Hypothesis 2: The cortical silent period will be the most sensitive measure investigated and will demonstrate significant increase in inhibition as determined by an elongation of silent period in the affected upper trapezius muscle.

Hypothesis 3: The stimulation location determined to be most effective in Objective 1 will produce the greatest physiologic change in inhibition increase.

Hypothesis 4: The hypothesis for this aim is if certain characteristics can predict response to treatment, a strong association will be seen between baseline measure(s) and the primary outcome measure. A thorough assessment of characteristics including: age, sex, duration of symptoms, genotyping for two specific polymorphisms, botulinum toxin history, baseline measures of outcome variables, measures of brain excitability, and genetic testing will predict response.

Conditions

  • Cervical Dystonia

Interventions

DEVICE

transcranial direct current stimulation

tDCS using a constant current of 2 mA via two 35 cm2 saline soaked sponge electrodes. Treatment is 1x/day for 4 days.

Sponsors & Collaborators

Principal Investigators

  • Teresa J Kimberley, PT, PhD · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2017-09-30
Completion
2017-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02180139 on ClinicalTrials.gov