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

Cervical Dystonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01859247
• Other study ID #: UNM 657
• Secondary ID: U54NS065701
• Status: Completed
• Phase: N/A
• First received: May 9, 2013
• Last updated: December 3, 2014
• Start date: March 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2014
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Dystonia
• Dystonia
• Dystonic Disorders
• Spasmodic Torticollis
• Torticollis

Intervention

Device:
• rTMS

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (5)

Lead Sponsor	Collaborator
University of New Mexico	Dystonia Coalition, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), University Health Network, Toronto

Country where clinical trial is conducted

United States, 

References & Publications (4)

Beck S, Houdayer E, Richardson SP, Hallett M. The role of inhibition from the left dorsal premotor cortex in right-sided focal hand dystonia. Brain Stimul. 2009 Oct;2(4):208-14. doi: 10.1016/j.brs.2009.03.004. Epub 2009 May 3. — View Citation

Breakefield XO, Blood AJ, Li Y, Hallett M, Hanson PI, Standaert DG. The pathophysiological basis of dystonias. Nat Rev Neurosci. 2008 Mar;9(3):222-34. doi: 10.1038/nrn2337. Review. — View Citation

Lefaucheur JP, Fénelon G, Ménard-Lefaucheur I, Wendling S, Nguyen JP. Low-frequency repetitive TMS of premotor cortex can reduce painful axial spasms in generalized secondary dystonia: a pilot study of three patients. Neurophysiol Clin. 2004 Oct;34(3-4):141-5. — View Citation

Murase N, Rothwell JC, Kaji R, Urushihara R, Nakamura K, Murayama N, Igasaki T, Sakata-Igasaki M, Mima T, Ikeda A, Shibasaki H. Subthreshold low-frequency repetitive transcranial magnetic stimulation over the premotor cortex modulates writer's cramp. Brain. 2005 Jan;128(Pt 1):104-15. Epub 2004 Oct 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)		Change from baseline pre-intervention TWSTRS score to post-intervention within 1 hour of treatment	No
Secondary	Dorsal Premotor-motor inhibition (dPMI)		Change from baseline dPMI to post-intervention within 1 hour of treatment	No
Secondary	Composite measure of patient rating of symptoms and tolerability	This measure will confirm the intervention tolerability by the patient. He/she will score the tolerability from 0-10, 0 being "completely tolerable" and 10 "completely untolerable."	Change from baseline dPMI to post-intervention within 1 hour of treatment	No

External Links

•   Dystonia Coalition