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tDCS in Cervical Dystonia

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ClinicalTrials.gov Identifier: NCT02180139
Recruitment Status : Withdrawn (Study was withdrawn due to lack of funding and staff availability.)
First Posted : July 2, 2014
Last Update Posted : October 3, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

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.


Condition or disease Intervention/treatment Phase
Cervical Dystonia Device: transcranial direct current stimulation Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Optimizing tDCS in Cervical Dystonia
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Experimental: Primary motor cortex (M1) stimulation
Treatment by transcranial direct current stimulation will be targeted to the motor cortex for all treatment sessions with Bilateral M1 with cathode to contralateral M1 and anode to ipsilateral M1, 15 minutes (Goal: decrease contralateral M1 excitability)
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.
Other Names:
  • Transcranial Technologies
  • TCT Research Limited, Kowloon, Hong Kong

Experimental: Cerebellum stimulation
Treatment with transcranial direct current stimulation will be targeted to the cerebellum at every session with anode to ipsilateral cerebellum with cathode to ipsilateral side of face, 15 minutes (Goal: increase ipsilateral cerebellum activation which exerts inhibitory effect on motor circuits)
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.
Other Names:
  • Transcranial Technologies
  • TCT Research Limited, Kowloon, Hong Kong

Experimental: Combined M1 and Cerebellum stimulation
Treatment with transcranial direct current stimulation will be placed with M1 anode contralateral + cerebellum anode. M1 will first be 'primed' with anode on contralateral M1, cathode on face, for 10 min, followed immediately by 15 min of cerebellar stimulation as in #2. (Goal: prime the contralateral M1 with increased excitability to engage a potentially larger effect from the following ipsilateral cerebellar stimulation that will be excited to exert inhibitory effect on the motor circuits including M1)
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.
Other Names:
  • Transcranial Technologies
  • TCT Research Limited, Kowloon, Hong Kong

Placebo Comparator: Sham stimulation
transcranial direct current stimulation will be given in placebo form. Sham stimulation: electrode placement will be same as M1. Sham tDCS will be applied by ramping down current intensity to 0 after 30 seconds following standard practice for sham tDCS.
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.
Other Names:
  • Transcranial Technologies
  • TCT Research Limited, Kowloon, Hong Kong




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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


Other Outcome Measures:
  1. Adverse reactions [ Time Frame: Day 1, Day 2, Day 3, Day 4 (all days with intervention) ]
    Adverse reactions will be recorded using established reporting forms.

  2. Genetic Testing [ Time Frame: Day 6 ]
    At the last session, a saliva sample will be collected for genetic screening for BDNF and apolipoprotein E4 polymorphisms. We will collect approximately 2 ml (less than one-half teaspoon) of saliva by asking the subject to spit into a tube. It may take up to 30 minutes to provide a saliva sample, however, most people typically require less time (approximately 5 minutes). Collection of saliva using Oragene Discover is non-invasive and there are no anticipated personal risks of injury.



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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 21-65 years of age
  2. Segmental dystonia, defined as dystonia in the neck plus another region is allowed, but CD must be primary source of disability.
  3. Medications for dystonia are allowed, but they must be on a stable dose for the duration of the experiment. Individuals may be receiving BTX injections, but must be on a 2-cycle stable dose prior to experiment (first SC visit). Individuals who do not take BTX are also allowed to participate.

Exclusion Criteria:

  1. Any surgical intervention or musculoskeletal impairment that would interfere with participation (eg., neck fusion, deep brain stimulation, peripheral denervation)
  2. secondary dystonia (eg., Parkinson syndrome)
  3. any neurologic or psychiatric disability that would interfere with participation
  4. pregnancy
  5. history of seizure within the last two years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180139


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Teresa J Kimberley, PT, PhD University of Minnesota - Clinical and Translational Science Institute

Publications:
Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02180139     History of Changes
Other Study ID Numbers: TDCS-2014
First Posted: July 2, 2014    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases