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Neurotoxin and Physical Therapy

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ClinicalTrials.gov Identifier: NCT02177617
Recruitment Status : Completed
First Posted : June 27, 2014
Last Update Posted : April 26, 2018
Sponsor:
Collaborators:
American Academy of Neurology
National Ataxia Foundation
American Brain Foundation
Information provided by (Responsible Party):
University of Florida

Brief Summary:
This study aims to compare Botox injections without Physical Therapy sessions to Botox injections combined with Physical Therapy sessions for treatment of Cervical Dystonia. It is expected that Botox combined with Physical Therapy will improve Cervical Dystonia symptoms and quality of life more than Botox alone. It is also expected that Botox combined with Physical Therapy will enhance neuroplasticity, or the ability of the brain to make new connections, more than Botox alone at 4-5 weeks, and remain improved at 12 weeks, after Botox injection.

Condition or disease Intervention/treatment Phase
Cervical Dystonia Drug: Botox injection Behavioral: Physical Therapy Procedure: Transcranial magnetic stimulation (TMS) Phase 4

Detailed Description:

The study will recruit primary cervical dystonia patients (age 18-80) who are stable on Allergan botulinum toxin type A (Botox). Patients will be randomized to receive their typical Botox injection alone, or with physical therapy.

At Baseline, disease characteristics (as measured by the Toronto Western Spasmodic Torticollis Rating Scale, or TWSTRS, and the Clinical Global Impression of Severity, or CGIS) will be measured, along with quality of life (from the Short Health 36 Survey Form 36, or SF-36). One subscale of the TWSTRS will be videotaped to be later evaluated by blinded movement disorder specialists. A pain scale will also be completed and range of head motion will be measured using a device similar to a protractor (called a goniometer). An individualized Botox injection will be administered, as well as transcranial magnetic stimulation (TMS) to measure neuroplasticity, or the ability of the brain to make new connections. If randomized to receive physical therapy, participants will also receive instructions to perform physical therapy exercises five times per week by a physical therapist who specializes in movement disorders. The investigator will call weekly to check how the participant is doing with the exercise program.

The same procedures outlined above will also be performed at 5 weeks past baseline, and at 12 weeks (except for the Botox injection, which will only be given at baseline and 12 weeks).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Synergistic Effects of Neurotoxin and Physical Therapy
Study Start Date : December 2014
Actual Primary Completion Date : January 7, 2017
Actual Study Completion Date : January 7, 2017


Arm Intervention/treatment
Active Comparator: Botox only
Participants randomized to receive Botox injections alone.
Drug: Botox injection
Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms
Other Name: Neurotoxin

Procedure: Transcranial magnetic stimulation (TMS)
For these tests, participants will sit in a chair that looks like one found at the dentist's office. A nerve stimulator will be placed on the wrist of the right hand to stimulate the median and ulnar nerves. The intensity of the nerve stimulator will be gradually increased until the right thumb begins to twitch. A magnetic coil will be placed on the scalp on the left side of the head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles in the opposite hand. This procedure will be repeated using the left wrist and the right side of the head.

Active Comparator: Botox plus Physical Therapy
Participants randomized to receive Botox injection combined with Physical Therapy
Drug: Botox injection
Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms
Other Name: Neurotoxin

Behavioral: Physical Therapy
Participants will undergo physical therapy sessions with a physical therapist trained in movement disorders. Participants will be instructed to continue these exercises five times per week, and will be called weekly by the investigator to check progress.

Procedure: Transcranial magnetic stimulation (TMS)
For these tests, participants will sit in a chair that looks like one found at the dentist's office. A nerve stimulator will be placed on the wrist of the right hand to stimulate the median and ulnar nerves. The intensity of the nerve stimulator will be gradually increased until the right thumb begins to twitch. A magnetic coil will be placed on the scalp on the left side of the head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles in the opposite hand. This procedure will be repeated using the left wrist and the right side of the head.




Primary Outcome Measures :
  1. Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) [ Time Frame: Change from Baseline to Week 12 ]
    The Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) is a measure of symptoms, pain, and disability related to Cervical Dystonia. The total TWSTRS scale includes a global outcome score (total score) and scores on each of 3 subscales for severity (0-35), disability (0-30), and pain (0-20), with higher scores indicating greater impairment. The TWSTRS is completed by a neurologist who visually assesses the patient's symptoms, and asks the patient to self-report on pain and disability.

  2. Short Form 36 Health Survey (SF-36) [ Time Frame: Change from Baseline to Week 12 ]
    The Short Form 36 Item Health Scale (SF-36) is a health survey with 36 questions that is self-reported by the study participant. It contains 8 subscales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health. The lower the score, the less disability.

  3. Clinical Global Impression Scale (CGIS) [ Time Frame: Change from Baseline to Week 12 ]
    This scale is an investigator- rated scale that measure illness severity on a single 7-point scale. Higher scores represent greater severity of illness.


Secondary Outcome Measures :
  1. Neuroplasticity Assessment [ Time Frame: Change from Baseline to Week 12 ]
    A standard transcranial magnetic stimulation (TMS) paired associative stimulation (PAS) protocol will be used to measure of neuroplasticity (the ability of the brain to form new connections). For these tests, participants will sit in a chair that looks like one found at the dentist's office. A nerve stimulator will be placed on the wrist of the right hand to stimulate the median and ulnar nerves. The intensity of the nerve stimulator will be gradually increased until the right thumb begins to twitch. A magnetic coil will be placed on the scalp on the left side of the head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles in the opposite hand. This procedure will be repeated using the left wrist and the right side of the head.


Other Outcome Measures:
  1. Visual Analog Scale [ Time Frame: Baseline to 12 weeks ]
    This is a single item scale, on which participants will mark the level of pain from 0-100. Higher score represents more severe pain.

  2. Cervical Range of Motion Measurement [ Time Frame: Baseline to 12 weeks ]
    Participants will be asked to sit in a chair and move the head to the left, to the right, to the front, and to the back. Then, participants be asked to tilt the head from side to side. A goniometer will be used to measure how far the head is able to move. The goniometer is similar to a protractor that measures magnitude of angle.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-80 with a diagnosis of Cervical Dystonia, which will be confirmed by a movement disorders specialist
  • Positive response to at least two prior treatments with Botox as indicated by an improvement in Clinical Global Improvement Scale.
  • Received last dose of Botox a minimum of 12 weeks prior to baseline visit.

Exclusion Criteria:

  • Any conditions that would contraindicate transcranial magnetic stimulation (for example, pregnancy or epilepsy)
  • Any secondary, fixed, post-traumatic, or psychogenic dystonia

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): NCT02177617


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32607
Sponsors and Collaborators
University of Florida
American Academy of Neurology
National Ataxia Foundation
American Brain Foundation
Investigators
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Principal Investigator: Aparna Wagle Shukla, MD University of Florida
Principal Investigator: Michael S Okun, MD University of Florida

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02177617     History of Changes
Other Study ID Numbers: IRB201400343
First Posted: June 27, 2014    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Florida:
Cervical Dystonia
Botox

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