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Primary Cervical DystoniaNCT02542839

rTMS and Botulinum Toxin in Primary Cervical Dystonia

A study testing NeuroStar TMS therapy, Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and Craniocervical Dystonia Questionnaire (CDQ-24) in people with Primary Cervical Dystonia and Dystonia, run by University of Florida at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 75 years
Conditions the study is for
Primary Cervical Dystonia, Dystonia
What is being tested?
NeuroStar TMS therapy, Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and Craniocervical Dystonia Questionnaire (CDQ-24)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
9 participants
Where
2 sitesUnited States
Study dates
Nov 2015to 28 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • UF Center for Movement Disorders & Neurorestoration

    Gainesville, Florida, 32607

  • UF Brain Institute

    Gainesville, Florida, 32611

Other trials in United States

About this study

Official title: Combined Therapy With 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.

Read the detailed description

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.

Being tested
NeuroStar TMS therapy, Sham NeuroStar TMS therapy, Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), Craniocervical Dystonia Questionnaire (CDQ-24), Cerebellar-brain Inhibition (CBI)
Keywords
Botulinum Toxin, Transcranial Magnetic Stimulation
Medical subject headings
Cervical Dystonia, Primary, Dystonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 or surgery

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

Study groups in NCT02542839
Study groupRoleWhat they receive
Real rTMS StimulationExperimentalRepetitive TMS will be delivered over each cerebellar hemisphere, using a NeuroStar TMS therapy system. The coil will be positioned 3 cm lateral to the inion on the line joining the inion and the external auditory meatus. The coil position will be marked on the skin. 900 pulses will be delivered consecutively to each side with a frequency of 1 Hz and at an intensity of 90% of the resting motor threshold (RMT) for a total duration of 15 min for each cerebellar hemisphere. The RMT will be defined as the lowest stimulation intensity required to evoke a 50 μV potential in a target muscle. Constant coil position will be continuously monitored during the experiment. A similar protocol will be observed for the contralateral cerebellum. In addition, this group will have the following performed: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) test, Cerebellar-brain Inhibition (CBI) measurement, and Craniocervical Dystonia Questionnaire (CDQ-24) questionnaire to fill out.
Receives: Device: NeuroStar TMS therapy; Other: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS); Other: Craniocervical Dystonia Questionnaire (CDQ-24); Other: Cerebellar-brain Inhibition (CBI); Procedure: Botulinum toxin injections
Sham rTMS StimulationSham comparatorPatients will undergo the same procedure for identifying stimulus location used in patients receiving real rTMS. Simulated rTMS will be administered using sham NeuroStar TMS therapy system coil which produces discharge noise and vibration without stimulating the cerebral cortex. This technique has been suggested to provide more effective blinding compared to other methods use in previous controlled studies. In addition, this group will have the following performed: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) test, Cerebellar-brain Inhibition (CBI) measurement, and Craniocervical Dystonia Questionnaire (CDQ-24) questionnaire to fill out.
Receives: Device: Sham NeuroStar TMS therapy; Other: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS); Other: Craniocervical Dystonia Questionnaire (CDQ-24); Other: Cerebellar-brain Inhibition (CBI); Procedure: Botulinum toxin injections

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: absolute value at 12 weeks

Secondary outcomes (2)

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

    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.

    Measured: absolute value at 12 weeks

  2. Craniocervical Dystonia Questionnaire

    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.

    Measured: absolute value at 12 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Sep 2015 (estimated)
  2. Study startNov 2015
  3. Primary completion28 Jun 2021
  4. Study completion28 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02542839
Sponsor's protocol ID
IRB201500341
Status last verified
Aug 2023
First submitted
23 Jun 2015
Last updated
22 Dec 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • Tarsy D, Simon DK. Dystonia. N Engl J Med. 2006 Aug 24;355(8):818-29. doi: 10.1056/NEJMra055549. No abstract available.

    PubMed 16928997

  • Phukan J, Albanese A, Gasser T, Warner T. Primary dystonia and dystonia-plus syndromes: clinical characteristics, diagnosis, and pathogenesis. Lancet Neurol. 2011 Dec;10(12):1074-85. doi: 10.1016/S1474-4422(11)70232-0. Epub 2011 Oct 24.

    PubMed 22030388

  • Jankovic J. Treatment of dystonia. Lancet Neurol. 2006 Oct;5(10):864-72. doi: 10.1016/S1474-4422(06)70574-9.

    PubMed 16987733

  • Dressler D, Tacik P, Saberi FA. Botulinum toxin therapy of cervical dystonia: duration of therapeutic effects. J Neural Transm (Vienna). 2015 Feb;122(2):297-300. doi: 10.1007/s00702-014-1253-8. Epub 2014 Jul 23.

    PubMed 25052566

  • Thenganatt MA, Jankovic J. Treatment of dystonia. Neurotherapeutics. 2014 Jan;11(1):139-52. doi: 10.1007/s13311-013-0231-4.

    PubMed 24142590

  • Hallett M. Transcranial magnetic stimulation: a primer. Neuron. 2007 Jul 19;55(2):187-99. doi: 10.1016/j.neuron.2007.06.026.

    PubMed 17640522

  • Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.

    PubMed 25034472

  • Wagle Shukla A, Vaillancourt DE. Treatment and physiology in Parkinson's disease and dystonia: using transcranial magnetic stimulation to uncover the mechanisms of action. Curr Neurol Neurosci Rep. 2014 Jun;14(6):449. doi: 10.1007/s11910-014-0449-5.

    PubMed 24771105

  • Rossi S, Ferro M, Cincotta M, Ulivelli M, Bartalini S, Miniussi C, Giovannelli F, Passero S. A real electro-magnetic placebo (REMP) device for sham transcranial magnetic stimulation (TMS). Clin Neurophysiol. 2007 Mar;118(3):709-16. doi: 10.1016/j.clinph.2006.11.005. Epub 2006 Dec 22.

    PubMed 17188568

Questions about this trial

What is this clinical trial studying?

A study testing NeuroStar TMS therapy, Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) and Craniocervical Dystonia Questionnaire (CDQ-24) in people with Primary Cervical Dystonia and Dystonia, run by University of Florida at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Sep 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dystonia Severity as Assessed by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) (time frame: absolute value at 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02542839, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2023.

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