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Effects of Botulinum Toxin on Muscle and Brain Activity

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ClinicalTrials.gov Identifier: NCT02837185
Recruitment Status : Recruiting
First Posted : July 19, 2016
Last Update Posted : June 11, 2018
Sponsor:
Collaborator:
Dystonia Medical Research Foundation
Information provided by (Responsible Party):
University of Florida

Brief Summary:
This study will look into the effects of Botulinum Toxin in patients with primary cervical dystonia. The effects will be determined by neck muscle activity measurements and brain function activity measurements. The goal of the study is to try to identify markers of the effects of Botulinum toxin.

Condition or disease Intervention/treatment Phase
Cervical Dystonia, Primary Procedure: Botulinum Toxin injection Other: Physiological measures Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Physiological Effects of Botulinum Toxin Therapy in Primary Cervical Dystonia
Actual Study Start Date : August 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018


Arm Intervention/treatment
Experimental: Cervical Dystonia
'Botulinum Toxin injection' will be done and 'physiological measures' will then be collected.
Procedure: Botulinum Toxin injection
Botulinum toxin injection for cervical dystonia subjects (as part of clinical care)

Other: Physiological measures
These include TMS and EMG measurements

Healthy controls
No Botulinum toxin is injected, 'physiological measures' will be collected as a healthy comparator.
Other: Physiological measures
These include TMS and EMG measurements




Primary Outcome Measures :
  1. Changes in TMS measures [ Time Frame: Baseline, BoNT ON (around 6 weeks), BoNT OFF (around 12 weeks) for Arm 1; Arm 2 measured only at baseline ]
  2. Changes in EMG measures [ Time Frame: baseline, BoNT ON (around 6 weeks), BoNT OFF (around 12 weeks) for Arm 1; Arm 2 measured only at baseline ]

Secondary Outcome Measures :
  1. Changes in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: 0, BoNT ON (around 6 weeks), BoNT OFF (around 12 weeks) for Arm 1 only ]
    Clinical measurement of cervical dystonia



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Ages Eligible for Study:   21 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Subject inclusion criteria:

  • Diagnosis: PCD
  • Receiving BoNT at the University of Florida (UF)

Subject exclusion criteria:

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

Control inclusion criteria:

  • Age 21-80 years

Control exclusion criteria:

  • Any form of torticollis
  • Pregnancy
  • Active seizure disorder
  • Presence of metallic body such as pacemaker, implants, metal rods and hearing aid

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02837185


Contacts
Contact: Wissam Deeb, MD wissam.deeb@neurology.ufl.edu
Contact: Aparna Wagle Shukla aparna.shukla@neurology.ufl.edu

Locations
United States, Florida
University of Florida Recruiting
Gainesville, Florida, United States, 32607
Contact: Wissam Deeb, MD       wissam.deeb@neurology.ufl.edu   
Sponsors and Collaborators
University of Florida
Dystonia Medical Research Foundation
Investigators
Principal Investigator: Aparna Wagle Shukla University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02837185     History of Changes
Other Study ID Numbers: IRB201600759
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by University of Florida:
Cervical dystonia
Transcranial magnetic stimulation
Electromyography
TMS
EMG

Additional relevant MeSH terms:
Dystonia
Dystonic Disorders
Torticollis
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs