- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02177617
Neurotoxin and Physical Therapy
Synergistic Effects of Neurotoxin and Physical Therapy
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32607
- University of Florida
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Botox only
Participants randomized to receive Botox injections alone.
|
Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms
Other Names:
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
|
Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms
Other Names:
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Time Frame: absolute value at 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), which are summed together for a total score (0-85), 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.
|
absolute value at Week 12
|
SF-36 Physical Functioning Subscore
Time Frame: absolute value at 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, one of which is Physical Functioning, calculated from 10 of the 36 questions. Different questions have different score ranges and valences. Therefore, their response for each question is linearly transformed to a value of 0-100 (for example, choosing response 3 on a scale of 1-5 is transformed to 60). These ten values are then averaged to generate the Physical Functioning subscore, ranging from 0-100. The higher the response value and the subscore, the higher degree of physical functioning. More details on RAND SF-36 scoring here: https://www.rand.org/health-care/surveys_tools/mos/36-item-short-form/scoring.html |
absolute value at Week 12
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Clinical Global Impression Scale (CGIS)
Time Frame: absolute value at Week 12
|
This scale is an investigator-rated scale that measures illness severity on a single 7-point scale (1-7).
Higher scores represent greater severity of illness.
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absolute value at Week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean MEP After Paired Associative Stimulation (PASmean)
Time Frame: absolute value at week 12
|
A standard transcranial magnetic stimulation (TMS) paired associative stimulation (PAS) protocol was used to measure of neuroplasticity (the ability of the brain to form new connections).
A nerve stimulator was placed on the wrist of the right hand to stimulate the median and ulnar nerves, set at the lowest intensity where the right thumb begins to twitch.
An EMG sensor was placed over the abductor pollicis brevis muscle to measure muscle contractions.
A magnetic coil was 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.
90 pairs of TMS and nerve stimulator pulses were applied.
Then the motor evoked potential (MEP) from a single TMS pulse recorded from the surface EMG of the abductor pollicis brevis muscle was determined immediately, at 15 min and at 30 min after completion of the PAS protocol.
The mean of these MEPs (PASmean) was compared between baseline and followup.
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absolute value at week 12
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual Analog Scale
Time Frame: absolute value at 12 weeks
|
This is a single item scale, on which participants will mark the level of pain from 0-10.
Higher score represents more severe pain.
|
absolute value at 12 weeks
|
Cervical Range of Motion Measurement
Time Frame: absolute value at 12 weeks was calculated
|
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.
A greater number indicates a greater range of motion.
The minimum score would be 0, with no definite maximum (would not clinically be expected to exceed 70 degrees).
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absolute value at 12 weeks was calculated
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aparna Wagle Shukla, MD, University of Florida
- Principal Investigator: Michael S Okun, MD, University of Florida
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB201400343
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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