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

NCT01859247 | Completed Results

• 2 other identifiers: UNM 657U54NS065701
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Dystonia; Spasmodic Torticollis

Keywords

cervical dystonia; torticollis; rTMS

Outcome Measures

Primary Outcomes (1)

• Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

  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).

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

Secondary Outcomes (2)

• Dorsal Premotor-motor Inhibition (dPMI)

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

• Composite Measure of Patient Rating of Symptoms and Tolerability

  Assessment completed immediately after rTMS treatment session

Study Arms (5)

Dorsal Premotor rTMS

ACTIVE COMPARATOR

0.2 Hz rTMS for 15 minutes

Device: rTMS

Primary motor cortex rTMS

ACTIVE COMPARATOR

0.2 Hz rTMS for 15 minutes

Device: rTMS

Supplemental Motor Area rTMS

ACTIVE COMPARATOR

0.2 Hz rTMS for 15 minutes

Device: rTMS

Anterior Cingulate rTMS

ACTIVE COMPARATOR

0.2 Hz rTMS for 15 minutes

Device: rTMS

Sham rTMS

SHAM COMPARATOR

0.2 Hz rTMS for 15 minutes

Device: rTMS

Interventions

rTMS DEVICE

Anterior Cingulate rTMS; Dorsal Premotor rTMS; Primary motor cortex rTMS; Sham rTMS; Supplemental Motor Area rTMS

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of New Mexico

Albuquerque, New Mexico, 87131, United States

Location

Related Publications (5)

• 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.

  PMID: 20633420 BACKGROUND

• 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.

  PMID: 18285800 BACKGROUND

• Lefaucheur JP, Fenelon G, Menard-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. doi: 10.1016/j.neucli.2004.07.003.

  PMID: 15501683 BACKGROUND

• 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. doi: 10.1093/brain/awh315. Epub 2004 Oct 13.

  PMID: 15483042 BACKGROUND

• Pirio Richardson S, Tinaz S, Chen R. Repetitive transcranial magnetic stimulation in cervical dystonia: effect of site and repetition in a randomized pilot trial. PLoS One. 2015 Apr 29;10(4):e0124937. doi: 10.1371/journal.pone.0124937. eCollection 2015.

  PMID: 25923718 DERIVED

MeSH Terms

Conditions

Torticollis

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Sarah Pirio Richardson, MD
• Organization: The University of New Mexico Health Sciences Center

spiriorichardson@salud.unm.edu

505-272-3342

Study Officials

• Sarah Pirio Richardson, MD

  University of New Mexico

  PRINCIPAL INVESTIGATOR

• H.A. Jinnah, MD

  Emory University

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 9, 2013
• First Posted: May 21, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: July 28, 2016
• Results First Posted: July 28, 2016

Record last verified: 2016-06

Locations

US (1)