CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 9 enrolled
Drug / intervention
NeuroStar TMS therapy +5 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02542839
NCT02542839N/ACompleted
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Combined Therapy With rTMS and Botulinum Toxin in Primary Cervical Dystonia

University of Florida·interventional·Posted Sep 7, 2015·Updated Dec 22, 2023

In Brief

A clinical study evaluating NeuroStar TMS therapy, Sham NeuroStar TMS therapy, and 4 other interventions for Primary Cervical Dystonia and Dystonia. Completed, enrolled 9 participants across 2 sites.

Detailed Summary

Primary cervical dystonia (PCD) is the most common form of focal dystonia. PCD is frequently reported as a source of disability, decreased quality of life, and social stigma. Botulinum toxin (BoNT) is the gold standard treatment for PCD. The average duration of benefits from BoNT injections was about 9.5 weeks and BoNT treatment is known to provide only pure symptomatic benefits and does not seem to modify the disease pathophysiology. The investigator plans to use repetitive transcranial magnetic stimulation (rTMS) therapy as an adjunctive therapy in combination with BoNT injections as a novel approach to treat PCD. The primary goal of this study is to compare standard treatment with BoNT versus BoNT combined with a two week course of rTMS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary Cervical Dystonia, Dystonia
CountriesUnited States
CollaboratorsAmerican Brain Foundation, Neuronetics

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 7, 2015
Enrollment StartNov 1, 2015
Primary CompletionJun 28, 2021
TodayJul 2, 2026
Enrollment to primary: 5.7 yearsPosted 10.8 years ago

Interventions

NeuroStar TMS therapydevice

Application of repetitious transcranial magnetic stimulation (TMS) pulses using NeuroStar device to a specific brain target at predefined stimulation parameters.

Sham NeuroStar TMS therapydevice

Same procedure as real rTMS without stimulating the cerebral cortex.

Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)other

All participants will receive a clinical assessment of dystonia severity by using the TWSTRS test.

Craniocervical Dystonia Questionnaire (CDQ-24)other

All participants will fill out the Craniocervical Dystonia Questionnaire (CDQ-24) quality of life questionnaire.

Cerebellar-brain Inhibition (CBI)other

All participants will have a measure of the cerebellar-brain inhibition(CBI) which will be conducted by using a TMS device determining the ability of the coil to activate the cerebellum.

Botulinum toxin injectionsprocedure

All participants will receive Botulinum toxin(BoNT) injections as part of their standard of care