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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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13 September 2021 |
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Main ID: |
NCT02542839 |
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Date of registration:
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23/06/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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rTMS and Botulinum Toxin in Primary Cervical Dystonia
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Scientific title:
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Combined Therapy With rTMS and Botulinum Toxin in Primary Cervical Dystonia |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02542839 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Aparna Wagle-Shukla, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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UF Center for Movement Disorders and Neurorestoration |
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Key inclusion & exclusion criteria
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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.
Age minimum:
30 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Primary Cervical Dystonia
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Dystonia
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Intervention(s)
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Device: NeuroStar TMS therapy
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Other: Cerebellar-brain Inhibition (CBI)
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Other: Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
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Device: Sham NeuroStar TMS therapy
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Other: Craniocervical Dystonia Questionnaire (CDQ-24)
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Procedure: Botulinum toxin injections
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Primary Outcome(s)
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Dystonia severity as assessed by the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
[Time Frame: Baseline to 12 weeks]
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Secondary Outcome(s)
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Quality of life as assessed by Craniocervical Dystonia Questionnaire
[Time Frame: Baseline to 12 Weeks]
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Physiological impact of TMS measured by Cerebellar Inhibition(CBI)
[Time Frame: Baseline to 12 weeks]
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Secondary ID(s)
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IRB201500341
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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