N/A N=8 Randomized Double-blind Treatment

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

Cervical Dystonia · Spasmodic Torticollis

Bottom Line

View on ClinicalTrials.gov: NCT01859247 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2016

Primary outcome: Primary: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) — -3.0; 0.25; -2.9; -1.5 units on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: rTMS (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of New Mexico
Primary completion: Jun 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)	-3.0; 0.25; -2.9; -1.5; -0.5	—
SECONDARY Dorsal Premotor-motor Inhibition (dPMI)	57.50; 2.10; 21.08; 32.21; 19.71	—
SECONDARY Composite Measure of Patient Rating of Symptoms and Tolerability	1.6; 1.6; 1.5; 0.9; 0.8	—

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.

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT01859247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.