tDCS in Cervical Dystonia

NCT02180139 | Withdrawn FDA Device

• 1 other identifier: TDCS-2014
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Dystonia

Outcome Measures

Primary Outcomes (1)

• Cervical Dystonia Questionnaire (CDQ-24)

  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.

  up to Day 6

Secondary Outcomes (3)

• Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

  Day 1, Day 5, Day 6

• Visual Analog Scale (VAS)

  Day 1, Day 5, Day 6

• Cortical Excitability as measured by transcranial magnetic stimulation

  Day 1, Day 5, Day 6

Other Outcomes (2)

• Adverse reactions

  Day 1, Day 2, Day 3, Day 4 (all days with intervention)

• Genetic Testing

  Day 6

Study Arms (4)

Primary motor cortex (M1) stimulation

EXPERIMENTAL

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

Cerebellum stimulation

EXPERIMENTAL

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

Combined M1 and Cerebellum stimulation

EXPERIMENTAL

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

Sham stimulation

PLACEBO COMPARATOR

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

Interventions

transcranial direct current stimulation DEVICE

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

Also known as: Transcranial Technologies, TCT Research Limited, Kowloon, Hong Kong

Cerebellum stimulation; Combined M1 and Cerebellum stimulation; Primary motor cortex (M1) stimulation; Sham stimulation

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Segmental dystonia, defined as dystonia in the neck plus another region is allowed, but CD must be primary source of disability.
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (4)

• Gandiga PC, Hummel FC, Cohen LG. Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation. Clin Neurophysiol. 2006 Apr;117(4):845-50. doi: 10.1016/j.clinph.2005.12.003. Epub 2006 Jan 19.

  PMID: 16427357 BACKGROUND

• Muller J, Wissel J, Kemmler G, Voller B, Bodner T, Schneider A, Wenning GK, Poewe W. Craniocervical dystonia questionnaire (CDQ-24): development and validation of a disease-specific quality of life instrument. J Neurol Neurosurg Psychiatry. 2004 May;75(5):749-53. doi: 10.1136/jnnp.2003.013441.

  PMID: 15090572 BACKGROUND

• Consky, E. S., Basinski, A., Belle, L., Ranawaya, R., & Lang, A. E. (1990). The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS): assessment of validity and inter-rater reliability. Neurology, 40(suppl 1), 445.

  BACKGROUND

• Salvia P, Champagne O, Feipel V, Rooze M, de Beyl DZ. Clinical and goniometric evaluation of patients with spasmodic torticollis. Clin Biomech (Bristol). 2006 May;21(4):323-9. doi: 10.1016/j.clinbiomech.2005.11.011. Epub 2006 Jan 19.

  PMID: 16427167 BACKGROUND

MeSH Terms

Conditions

Torticollis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dystonia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Teresa J Kimberley, PT, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: September 1, 2017
• Primary Completion: September 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 3, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)