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Completed

NCT Number: NCT01859247

Identification of Optimal Stimulation Site for Cervical Dystonia Symptoms: An Exploratory Study

The overall objective of this application is to therapeutically target the dysfunctional premotor-motor interaction in dystonia-and to provide a focused treatment of specific anatomical networks in order to reduce side effects and to improve symptom control over conventional therapies.

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Key information

Conditions

Cervical Dystonia Dyskinesias Dystonia Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasmodic Torticollis Torticollis

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of New Mexico

Albuquerque, New Mexico, 87131, United States

About this study

We propose using repetitive transcranial magnetic stimulation (rTMS) over distinct premotor areas in patients with cervical dystonia (CD) with the goal of improving symptoms and reducing unwanted side effects. The knowledge gained in this proposed research will identify a specific premotor area to be targeted with rTMS that is expected to result in a novel intervention that could enhance or replace current treatments for CD. rTMS could be included as an adjunct treatment to botulinum toxin that could sustain treatment effect and decrease the frequency of re-injection, potentially resulting in cost savings without a decrease in symptom control. In addition to medical cost reduction, improved quality of life could be expected with the successful development of therapies that extend dystonia symptom control. rTMs has been FDA-approved for the treatment of depression and our proposal uses an even lower stimulation rate, suggesting continued use within clearly safe parameters. Successful completion of this research could lead to rapid adoption of this therapeutic modality.

We will test the hypothesis that rTMS of a distinct premotor site will provide more effective treatment of CD than non-specific activation of the entire premotor region. This will be done by performing a randomized, observer-blinded exploratory pilot study to determine the optimal site of rTMS over various sites of the premotor and motor cortex to improve the symptoms of cervical dystonia. Completion of this aim should lead to development of targeted TMS therapy for CD.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of idiopathic cervical dystonia
  • Age 18 years or older
  • Normal findings in the medical history, physical and neurological examination, except for dystonia
  • Last treatment with botulinum toxin more than two months ago

Exclusion criteria

  • History of seizure disorder
  • Pregnancy- a pregnancy test will be performed for women of childbearing potential
  • History of any other neurological disorders or conditions requiring the use of anti-depressants that are known to increase seizure threshold, neuroleptic medication, anticholinergic drugs and muscle relaxants
  • History of neuroleptic medications/ prior use of neuroleptics

Treatment and study plan

rTMS

Device

Primary outcomes

  1. Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

    Time frame: Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment

    Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was used to assess severity of disease. The score for this section ranges from 0 (absence of severity) to 35 (maximum severity).

Secondary outcomes

  1. Dorsal Premotor-motor Inhibition (dPMI)

    Time frame: Change from baseline dPMI to post-intervention within 1 hour of treatment

  2. Composite Measure of Patient Rating of Symptoms and Tolerability

    Time frame: Assessment completed immediately after rTMS treatment session

    This measure will confirm the intervention tolerability by the patient. He/she scored the tolerability from 0-10, 0 being "completely tolerable" and 10 "completely intolerable."

Sponsors and collaborators

Lead sponsor

University of New Mexico

Other

Collaborators

  • Dystonia Coalition
  • National Institute of Neurological Disorders and Stroke (NINDS)
  • National Institutes of Health (NIH)
  • University Health Network, Toronto

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 21, 2013
Registry last updated
Jul 28, 2016

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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