Skip to main content
OpenTrials
Completed

NCT Number: NCT02542839

rTMS and Botulinum Toxin in Primary Cervical Dystonia

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Primary Cervical Dystonia Cervical Dystonia, Primary Dyskinesias Dystonia Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Brain Institute, Gainesville, Florida, United States

Loading trial locations.

About this study

rTMS refers to the application of transcranial magnetic stimulation (TMS) pulses to a specific target at predefined stimulation parameters. Repeated sessions of rTMS therapy have been demonstrated to induce cumulative persistent benefits that can last weeks after the conclusion of the rTMS sessions

The central hypothesis of this study is that rTMS therapy in PCD can potentiate the effects of BoNT injections. With the current standard treatment, the peak-dose benefits seen with BoNT are seen at about 4-6 weeks after the administration of injections. The investigator will introduce a 1 week course of rTMS around 2-8 weeks before or after BoNT or T1). The investigator will examine the effects of combined therapy at 10 weeks after BoNT and 12 weeks after BoNT injections follow-up.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of PCD in accordance with the Consensus Statement of the Movement Disorder Society
  • Subjects who report Botulinum Toxin benefits lasting 10 weeks or less only (suboptimal benefits with standard care)

Exclusion criteria

  • Pregnancy
  • Active seizure disorder
  • Presence of a metallic body such as pacemaker, implants, metal rods and hearing aid.

Treatment and study plan

NeuroStar TMS therapy

Device

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

Sham NeuroStar TMS therapy

Device

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 injections

Procedure

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

Primary outcomes

  1. Dystonia Severity as Assessed by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)

    Time frame: absolute value at 12 weeks

    A clinical assessment of dystonia severity will be conducted at each study visit using the TWSTRS. The TWSTRS is a widely accepted composite rating scale for PCD with subscales for clinical severity, functional disability, and associated pain. The total score reported here can range 0-85, where a higher scores represent greater dystonia severity.

Secondary outcomes

  1. TMS Measure Referred to as Cerebellar Inhibition (CBI)

    Time frame: absolute value at 12 weeks

    A measure of the cerebellar-brain inhibition(CBI) will be conducted using a TMS device determining the ability of the coil to activate the cerebellum. CBI is calculated by taking the mean of amplitudes of motor-evoked potentials (mV) in response to conditioned stimulation and dividing it by the mean of amplitudes of motor-evoked potentials (mV) in response to unconditioned stimulation (i.e., the control condition). Thus it is a measure of the degree of inhibition due to a conditioning stimulus, where <1 indicates inhibition, =1 indicates no inhibition, and >1 indicates not inhibition but excitation. As a ratio of amplitudes, it does not have units.

  2. Craniocervical Dystonia Questionnaire

    Time frame: absolute value at 12 Weeks

    The Craniocervical Dystonia Questionnaire (CDQ-24) is a patient-rated health related quality of life (HR-QoL) measure for craniocervical dystonia. It is composed of 24 items, forming 5 subscales: stigma, emotional well-being, pain, activities of daily living, and social/ family life. Items are rated on a 5-point scale. Each item consists of five statements representing increasing severity of impairment, scored from 0 to 4. Subjects will be instructed to indicate how they have felt during the past two weeks because of dystonia by selecting one of the five statements for each item. The total score reported here can range from 0-96, with a higher score indicating a greater impact of dystonia on quality of life.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • American Brain Foundation
  • Neuronetics

Registry information

Official study title

Combined Therapy With rTMS and Botulinum Toxin in Primary Cervical Dystonia

Important dates

Study start
2015
Primary completion
2021
Study completion
2021
First posted
Sep 7, 2015
Registry last updated
Dec 22, 2023

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.