Cervical DystoniaPhase 4NCT02177617
Neurotoxin and Physical Therapy
A Phase 4 study testing Botox injection, Physical Therapy and Transcranial magnetic stimulation (TMS) in people with Cervical Dystonia, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cervical Dystonia
- What is being tested?
- Botox injection, Physical Therapy and Transcranial magnetic stimulation (TMS)
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 7 Jan 2017
- Phase
- Phase 4
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Any conditions that would contraindicate transcranial magnetic stimulation (for example, pregnancy or epilepsy)
- Any secondary, fixed, post-traumatic, or psychogenic dystonia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Synergistic Effects of Neurotoxin and Physical Therapy
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.
Read the 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).
- Conditions
- Cervical Dystonia
- Being tested
- Botox injection, Physical Therapy, Transcranial magnetic stimulation (TMS)
- Keywords
- Cervical Dystonia, Botox
- Medical subject headings
- Torticollis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox injectionDrug
Also called Neurotoxin
Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms
Physical TherapyBehavioural
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.
Transcranial magnetic stimulation (TMS)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Botox only | Active comparator | Participants randomized to receive Botox injections alone. Receives: Drug: Botox injection; Procedure: Transcranial magnetic stimulation (TMS) |
| Botox plus Physical Therapy | Active comparator | Participants randomized to receive Botox injection combined with Physical Therapy Receives: Drug: Botox injection; Behavioral: Physical Therapy; Procedure: Transcranial magnetic stimulation (TMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
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.
Measured: absolute value at Week 12
SF-36 Physical Functioning Subscore
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
Measured: absolute value at Week 12
Clinical Global Impression Scale (CGIS)
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.
Measured: absolute value at Week 12
Secondary outcomes (1)
Mean MEP After Paired Associative Stimulation (PASmean)
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.
Measured: absolute value at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startDec 2014
- Primary completion7 Jan 2017
- Study completion7 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical DystoniaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- American Academy of Neurology, National Ataxia Foundation, American Brain Foundation
- Responsible party
- Sponsor
- Investigators
- Aparna Wagle Shukla, MD, Principal investigator, University of FloridaMichael S Okun, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177617
- Sponsor's protocol ID
- IRB201400343
- Status last verified
- Aug 2023
- First submitted
- 13 Jun 2014
- Last updated
- 2 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Synergistic Effects of Neurotoxin and Physical Therapy
- ClinicalTrials.gov ID
- NCT02177617
- Acronym / sponsor ID
- IRB201400343
- Conditions
- Cervical Dystonia
- Keywords
- Cervical Dystonia, Botox
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- American Academy of Neurology, National Ataxia Foundation, American Brain Foundation
- Study start
- Dec 2014
- Primary completion
- 7 Jan 2017 (actual)
- Study completion
- 7 Jan 2017 (actual)
- First posted
- 27 Jun 2014 (estimated)
- Results
- Posted 2 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botox only | Active comparator | Drug: Botox injection, Procedure: Transcranial magnetic stimulation (TMS)Participants randomized to receive Botox injections alone. |
| Botox plus Physical Therapy | Active comparator | Drug: Botox injection, Behavioral: Physical Therapy, Procedure: Transcranial magnetic stimulation (TMS)Participants randomized to receive Botox injection combined with Physical Therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Any conditions that would contraindicate transcranial magnetic stimulation (for example, pregnancy or epilepsy)
- Any secondary, fixed, post-traumatic, or psychogenic dystonia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botox injectionAlso: NeurotoxinParticipants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms | Drug | Botox only, Botox plus Physical Therapy |
| Physical TherapyParticipants 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. | Behavioural | Botox plus Physical Therapy |
| 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. | Procedure or surgery | Botox only, Botox plus Physical Therapy |
Primary outcome
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.
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
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.
1 secondary outcome
Mean MEP After Paired Associative Stimulation (PASmean)
Time frame: absolute value at week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aparna Wagle Shukla, MD principal investigator
University of Florida
Michael S Okun, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Botox injection, Physical Therapy and Transcranial magnetic stimulation (TMS) in people with Cervical Dystonia, run by University of Florida at 1 site 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 3 inclusion and 2 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 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 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?
Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) (time frame: absolute value at Week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Aug 2023; AzTrials last refreshed its copy on 28 Oct 2026.