Clinical Trial: tDCS in Cervical Dystonia

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Optimizing tDCS in Cervical Dystonia

Brief 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.

Study Purpose

This study will investigate the use of an experimental research device called transcranial direct current stimulation (tDCS). tDCS is a way to stimulate the brain with potential therapeutic benefits. It works by either increasing or decreasing brain excitability. This is done by delivering a current to the outside of the head. This weak electrical current then passes through the skull and modulates the underlying brain tissue. Genetic factors may contribute to the effectiveness of this intervention; therefore, a saliva sample will be collected to assess the status of two genes: Brain derived neurotrophic factor (BDNF) and apolipoprotein E4. Our purpose is to determine the best location of stimulation for tDCS that improves the symptoms and quality of life in people with CD. The results of this study will help to identify alternative interventions for people with cervical dystonia. Brain excitability will be measured using an additional form of non-invasive brain stimulation, specifically by a device called a transcranial magnetic stimulator. By applying a magnetic field to the outside of the head, electrical currents are produced within the brain that can transiently affect brain activity and be recorded though electrodes on your skin. Using this procedure, different areas of the brain can be studied to gain a greater understanding of the brain physiology in patients with cervical dystonia.

Procedures

Intervention: Briefly, non-invasive brain stimulation can be delivered safely and painlessly via different mechanisms with the goal of either exciting or inhibiting the underlying brain issue. In focal dystonia, as indicated above, there is thought to be a lack of inhibition, thus settings are typically used to increase inhibition. Transcranial direct current sti
Sponsor: University of Minnesota - Clinical and Translational Science Institute

Current Primary Outcome: Cervical Dystonia Questionnaire (CDQ-24) [ Time Frame: up to Day 6 ]

This primary outcome was selected because it is a patient-rated, disease-specific assessment of quality of life, which we feel should be the primary issue of concern.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Day 1, Day 5, Day 6 ]
    Toronto Western Spasmodic Torticollis Rating Scale is an outcome measure used to rate severity, disability and pain in CD. TWSTRS utilizes three sub-scores of physician-based severity (0-35), patient-based disability (0-30) and pain (0-20) with higher scores indicating greater severity of symptoms. Inter-observer reliability is excellent (rs=99) and good for disability and pain measurements (r˃0.88). The global severity scale was moderate (rs=0.63). TWSTRS exam will be videotaped for posthoc assessment by investigator blinded to group and testing period.
  • Visual Analog Scale (VAS) [ Time Frame: Day 1, Day 5, Day 6 ]
    At the end of each intervention session participants will be asked to rate the ease of movement and perceived pain during cervical rotation in the contralateral direction to their head turn using VAS for self-assessment.
  • Cortical Excitability as measured by transcranial magnetic stimulation [ Time Frame: Day 1, Day 5, Day 6 ]
    Single and paired pulse testing to assess GABAergic and glutaminergic network function


Original Secondary Outcome: Same as current

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: June 30, 2014
Date Started: September 2017
Date Completion: December 2017
Last Updated: April 19, 2017
Last Verified: April 2017