DystoniaPhase 1/2NCT02015039
Pilot Trial of Botulinum Toxin and Occupational Therapy for Writer's Cramp
A Phase 1/2 study testing BoNT Injections and Occupational Therapy in people with Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Objective: Writer s cramp (WC) is a form of focal hand dystonia (FHD). Focal injections of botulinum toxin (BoNT) are the current best therapy. Past studies showed that some types of rehabilitative therapy can be useful. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Dystonia
- What is being tested?
- BoNT Injections and Occupational Therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2013to 13 Sep 2016
- Phase
- Phase 1/2
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be at least 18 years of age
- have writer s cramp
- patients are enrolled in 93-N-0202 and 85-N-0195
- willing to be videotaped while writing
- have normal hand function other than FHD
- be willing to use therapeutic daily rehabilitative therapies as prescribed
- have some positive subjective response to BoNT demonstrated on at least two prior treatments
- be able to comprehend and perform the daily activities required for those who are involved in combined therapy.
Who cannot join
- BoNT administration within 3 months of participation
- No response to BoNT
- Unable to provide consent
- Patients taking oral medications for WC including muscle relaxants or other centrally-active medications such as antidepressants which may enhance tremors
- Medical conditions that affect hand function, such as stroke, nerve entrapment, tremor, parkinsonism, chorea, ataxia affecting the dominant hand
- Unable to provide consent
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Objective: Writer s cramp (WC) is a form of focal hand dystonia (FHD). Focal injections of botulinum toxin (BoNT) are the current best therapy. Past studies showed that some types of rehabilitative therapy can be useful. The hypothesis of this study is that BoNT together with a specific type of occupational therapy will be better than BoNT alone for treating these patients. Additionally, studies on WC were hampered by the lack of objective, validated rating scales. In this pilot study, we will assess the value of a new scale compared with older scales.
Study population: The study population will consist of 12 WC patients (accrual ceiling of 16).
Read more
Design: Patients will be randomized so that 6 patients will receive just BoNT therapy and 6 patients will receive BoNT therapy plus occupational therapy. The physical therapy will involve specific exercises of finger movements in the direction opposite to the patient s own dystonic movements, during the writing task. The movements will be isometric against splints made to suit the individual patient. The final outcome will be assessed after 20 weeks of treatment. Patients will be evaluated on several scales, including the writer s cramp rating scale (WCRS) and writer s cramp impairment scale (WCIS), and will also be videotaped. The primary outcome will be based on patient reported subjective scale and the secondary outcomes will be assessed by four blinded raters of the videotapes, done both before and after treatment.
Outcome measures: The primary outcome is to show additional improvement from baseline with BoNT therapy plus occupational therapy compared to BoNT alone at 20 weeks using a patient-rated subjective scale. The secondary outcomes are to show improvement in scores of WCRS, WCIS, WCDS, and writing parameters with a new handwriting analysis program. Additionally, the scores obtained from WCRS and WCIS will be compared.
Read the detailed description
Objective: Writer s cramp (WC) is a form of focal hand dystonia (FHD). Focal injections of botulinum toxin (BoNT) are the current best therapy. Past studies showed that some types of rehabilitative therapy can be useful. The hypothesis of this study is that BoNT together with a specific type of occupational therapy will be better than BoNT alone for treating these patients. Additionally, studies on WC were hampered by the lack of objective, validated rating scales. In this pilot study, we will assess the value of a new scale compared with older scales.
Study population: The study population will consist of 12 WC patients (accrual ceiling of 16).
Design: Patients will be randomized so that 6 patients will receive just BoNT therapy and 6 patients will receive BoNT therapy plus occupational therapy. The physical therapy will involve specific exercises of finger movements in the direction opposite to the patient s own dystonic movements, during the writing task. The movements will be isometric against splints made to suit the individual patient. The final outcome will be assessed after 20 weeks of treatment. Patients will be evaluated on several scales, including the writer s cramp rating scale (WCRS) and writer s cramp impairment scale (WCIS), and will also be videotaped. The primary outcome will be based on patient reported subjective scale and the secondary outcomes will be assessed by four blinded raters of the videotapes, done both before and after treatment.
Outcome measures: The primary outcome is to show additional improvement from baseline with BoNT therapy plus occupational therapy compared to BoNT alone at 20 weeks using a patient-rated subjective scale. The secondary outcomes are to show improvement in scores of WCRS, WCIS, WCDS, and writing parameters with a new handwriting analysis program. Additionally, the scores obtained from WCRS and WCIS will be compared.
- Conditions
- Dystonia
- Being tested
- BoNT Injections, Occupational Therapy
- Keywords
- Occupational Therapy, Botulinum Toxin, Writer's Cramp
- Medical subject headings
- Dystonia, Dystonic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoNT InjectionsDrug
Occupational TherapyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Botulinum Toxin Therapy Only | Active comparator | Not described Receives: Drug: BoNT Injections |
| Botulinum Toxin Therapy plus Occupational Therapy | Experimental | Intervention Receives: Drug: BoNT Injections; Procedure: Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Using a Patient Rated Subjective Scale (Visual Analogue Scale), Change From Baseline With Botulinum Toxin Therapy Plus Occupational Therapy Compared to Botulinum Toxin Therapy Alone at 20 Weeks.
A visual analogue scale was used to rate patient's subjective rating of the severity of their writer's cramp at each visit. Patients were asked to mark the location on a 10 centimeter line corresponding to the severity of their writer's cramp. Ratings ranged from "mild" disease severity to "severe" disease severity. The mark was measured on the 10 centimeter line, ranging from 0 to 10. The percent change in the patient rated subject scale was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups.
Measured: Baseline and 20 weeks
Secondary outcomes (6)
Change in the Writers Cramp Rating Scale (WCRS) From Baseline to Week 20 in Participants Receiving Botulinum Toxin Therapy Alone Compared With Botulinum Toxin Therapy Plus Occupational Therapy.
The Writers Cramp Rating Scale (WCRS) is a tool used to quantify the treatment effect of local botulinum toxin injections in writer's cramp using writing performance and a computer assisted analysis of writing speed. The WCRS consists of two parts. Part A provides a writing movement score measuring 1) dystonic posture elbow score (ES: 0-2), 2) wrist score (WRS: 0-4), 3) finger score (FS: 0-6), 4) latency of dystonia (L: 1-2) and 5) writing tremor (WT: 0-2). The writing movement sub-score is calculated as (ES + WRS + FS) x L + (WT x 2) (0-28). Part B provides an assessment of writing speed (WS: 0-2). The WCRS score is the total of the writing movement sub-score and the writing speed sub-score. The total WCRS range is between "0" indicating absent residual writer's cramp symptoms to "30" indicating severe writer's cramp symptoms. The percentage change in the WCRS was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups.
Measured: Baseline and 20 weeks
Change on the Writer's Cramp Impairment Scale (WCIS) Score From Baseline to 20 Weeks.
The Writer's Cramp Impairment Scale (WCIS) scale assesses the speed of writing, the number of breaks during writing, the occurrence and intensity of involuntary (pathological) postures/abnormal movements (while writing, while performing repetitive wrist movements), the degree of tremor that occurs while performing repetitive spiral movements, and the presence of mirror movements. The scale ranges from 0-180 with 0 representing "no impairment" and 180 representing "severe impairment". The percent change in the WCIS was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups.
Measured: Baseline and 20 weeks
Change on the Writer's Cramp Disability Scale (WCDS) Score From Baseline to 20 Weeks.
The Writer's Cramp Disability Scale (WCDS) is a self-reported questionnaire which queries patients regarding problems they experience with writing and other every day activities due to writer's cramp. The scale ranges from 0-42 with 0 representing "no difficulty" and 42 representing "marked difficulty". The percent change in the WCDS was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups.
Measured: Baseline and 20 weeks
Change in Hand Grip Strength From Baseline to 20 Weeks Following Botulinum Toxin Therapy Alone and Botulinum Toxin Therapy Plus Occupational Therapy.
Hand grip strength was measured using a commercially available dynamometer. The dynamometer instrument measures maximum isometric strength of the hand and forearm muscles. Hand grip strength was measured with the dynamometer during each visit. The percent change in hand grip strength between baseline (Visit 1) and 20 weeks (Visit 8) in the two groups.
Measured: Baseline and 20 weeks
Change in Quantitative Writing Metrics Obtained Via Numerical Analyses of Writing Samples Using a Digitizing Tablet.
Subjects with writer's cramp were instructed to draw with their dominant hand between the lines of a 5-loop Archimedes spiral presented on a paper placed over the surface of a digitizing tablet sampling pen tip position at a 100 Hz. The deviation of the drawn spiral to the ideal spiral was calculated at each sampled point. The root mean square of the total spiral error was used as a measure of dysfunctional pen control in subjects with writer's cramp compared with normative data. The percent change of the root mean square was calculated at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups.
Measured: Baseline and 20 weeks
Using a Patient Rated Subjective Scale (Visual Analogue Scale), Change From Baseline With Botulinum Toxin Therapy Plus Occupational Therapy Compared to Botulinum Toxin Therapy Alone at 24 Weeks.
A visual analogue scale was used to rate patient's subjective rating of the severity of their writer's cramp at each visit. Patients were asked to mark the location on a 10 centimeter line corresponding to the severity of their writer's cramp. Ratings ranged from "mild" disease severity to "severe" disease severity. The mark was measured on the 10 centimeter line, ranging from 0 to 10. The percent change in the patient rated subject scale was measured at baseline (Visit 1) and 24 weeks (Visit 9) in the two groups.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2013 (estimated)
- Study start3 Dec 2013
- Primary completion13 Sep 2016
- Study completion13 Sep 2016
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.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for DystoniaStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02015039
- Sponsor's protocol ID
- 140030
- Other IDs
- 14-N-0030
- Status last verified
- 13 Feb 2018
- First submitted
- 13 Dec 2013
- Last updated
- 20 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Zeuner KE, Bara-Jimenez W, Noguchi PS, Goldstein SR, Dambrosia JM, Hallett M. Sensory training for patients with focal hand dystonia. Ann Neurol. 2002 May;51(5):593-8. doi: 10.1002/ana.10174.
PubMed 12112105Zeuner KE, Hallett M. Sensory training as treatment for focal hand dystonia: a 1-year follow-up. Mov Disord. 2003 Sep;18(9):1044-7. doi: 10.1002/mds.10490.
PubMed 14502673Zeuner KE, Shill HA, Sohn YH, Molloy FM, Thornton BC, Dambrosia JM, Hallett M. Motor training as treatment in focal hand dystonia. Mov Disord. 2005 Mar;20(3):335-41. doi: 10.1002/mds.20314.
PubMed 15486996
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Botulinum Toxin and Occupational Therapy for Writer's Cramp
- ClinicalTrials.gov ID
- NCT02015039
- Acronym / sponsor ID
- 140030
- Conditions
- Dystonia
- Keywords
- Occupational Therapy, Botulinum Toxin, Writer's Cramp
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 3 Dec 2013
- Primary completion
- 13 Sep 2016 (actual)
- Study completion
- 13 Sep 2016 (actual)
- First posted
- 19 Dec 2013 (estimated)
- Results
- Posted 23 Jan 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: Writer s cramp (WC) is a form of focal hand dystonia (FHD). Focal injections of botulinum toxin (BoNT) are the current best therapy. Past studies showed that some types of rehabilitative therapy can be useful. The hypothesis of this study is that BoNT together with a specific type of occupational therapy will be better than BoNT alone for treating these patients. Additionally, studies on WC were hampered by the lack of objective, validated rating scales. In this pilot study, we will assess the value of a new scale compared with older scales.
Study population: The study population will consist of 12 WC patients (accrual ceiling of 16).
Design: Patients will be randomized so that 6 patients will receive just BoNT therapy and 6 patients will receive BoNT therapy plus occupational therapy. The physical therapy will involve specific exercises of finger movements in the direction opposite to the patient s own dystonic movements, during the writing task. The movements will be isometric against splints made to suit the individual patient. The final outcome will be assessed after 20 weeks of treatment. Patients will be evaluated on several scales, including the writer s cramp rating scale (WCRS) and writer s cramp impairment scale (WCIS), and will also be videotaped. The primary outcome will be based on patient reported subjective scale and the secondary outcomes will be assessed by four blinded raters of the videotapes, done both before and after treatment.
Outcome measures: The primary outcome is to show additional improvement from baseline with BoNT therapy plus occupational therapy compared to BoNT alone at 20 weeks using a patient-rated subjective scale. The secondary outcomes are to show improvement in scores of WCRS, WCIS, WCDS, and writing parameters with a new handwriting analysis program. Additionally, the scores obtained from WCRS and WCIS will be compared.
Detailed description
Objective: Writer s cramp (WC) is a form of focal hand dystonia (FHD). Focal injections of botulinum toxin (BoNT) are the current best therapy. Past studies showed that some types of rehabilitative therapy can be useful. The hypothesis of this study is that BoNT together with a specific type of occupational therapy will be better than BoNT alone for treating these patients. Additionally, studies on WC were hampered by the lack of objective, validated rating scales. In this pilot study, we will assess the value of a new scale compared with older scales.
Study population: The study population will consist of 12 WC patients (accrual ceiling of 16).
Design: Patients will be randomized so that 6 patients will receive just BoNT therapy and 6 patients will receive BoNT therapy plus occupational therapy. The physical therapy will involve specific exercises of finger movements in the direction opposite to the patient s own dystonic movements, during the writing task. The movements will be isometric against splints made to suit the individual patient. The final outcome will be assessed after 20 weeks of treatment. Patients will be evaluated on several scales, including the writer s cramp rating scale (WCRS) and writer s cramp impairment scale (WCIS), and will also be videotaped. The primary outcome will be based on patient reported subjective scale and the secondary outcomes will be assessed by four blinded raters of the videotapes, done both before and after treatment.
Outcome measures: The primary outcome is to show additional improvement from baseline with BoNT therapy plus occupational therapy compared to BoNT alone at 20 weeks using a patient-rated subjective scale. The secondary outcomes are to show improvement in scores of WCRS, WCIS, WCDS, and writing parameters with a new handwriting analysis program. Additionally, the scores obtained from WCRS and WCIS will be compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Botulinum Toxin Therapy Only | Active comparator | Drug: BoNT Injections |
| Botulinum Toxin Therapy plus Occupational Therapy | Experimental | Drug: BoNT Injections, Procedure: Occupational TherapyIntervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
Key exclusion criteria (6 listed)
- BoNT administration within 3 months of participation
- No response to BoNT
- Unable to provide consent
- Patients taking oral medications for WC including muscle relaxants or other centrally-active medications such as antidepressants which may enhance tremors
- Medical conditions that affect hand function, such as stroke, nerve entrapment, tremor, parkinsonism, chorea, ataxia affecting the dominant hand
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 |
|---|---|---|
| BoNT Injections | Drug | Botulinum Toxin Therapy Only, Botulinum Toxin Therapy plus Occupational Therapy |
| Occupational Therapy | Procedure or surgery | Botulinum Toxin Therapy plus Occupational Therapy |
Primary outcome
Using a Patient Rated Subjective Scale (Visual Analogue Scale), Change From Baseline With Botulinum Toxin Therapy Plus Occupational Therapy Compared to Botulinum Toxin Therapy Alone at 20 Weeks.
Time frame: Baseline and 20 weeks
A visual analogue scale was used to rate patient's subjective rating of the severity of their writer's cramp at each visit. Patients were asked to mark the location on a 10 centimeter line corresponding to the severity of their writer's cramp. Ratings ranged from "mild" disease severity to "severe" disease severity. The mark was measured on the 10 centimeter line, ranging from 0 to 10. The percent change in the patient rated subject scale was measured at baseline (Visit 1) and 20 weeks (Visit 8) in the two groups.
6 secondary outcomes
Change in the Writers Cramp Rating Scale (WCRS) From Baseline to Week 20 in Participants Receiving Botulinum Toxin Therapy Alone Compared With Botulinum Toxin Therapy Plus Occupational Therapy.
Time frame: Baseline and 20 weeks
Change on the Writer's Cramp Impairment Scale (WCIS) Score From Baseline to 20 Weeks.
Time frame: Baseline and 20 weeks
Change on the Writer's Cramp Disability Scale (WCDS) Score From Baseline to 20 Weeks.
Time frame: Baseline and 20 weeks
Change in Hand Grip Strength From Baseline to 20 Weeks Following Botulinum Toxin Therapy Alone and Botulinum Toxin Therapy Plus Occupational Therapy.
Time frame: Baseline and 20 weeks
Change in Quantitative Writing Metrics Obtained Via Numerical Analyses of Writing Samples Using a Digitizing Tablet.
Time frame: Baseline and 20 weeks
Using a Patient Rated Subjective Scale (Visual Analogue Scale), Change From Baseline With Botulinum Toxin Therapy Plus Occupational Therapy Compared to Botulinum Toxin Therapy Alone at 24 Weeks.
Time frame: Baseline and 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12112105Zeuner KE, Bara-Jimenez W, Noguchi PS, Goldstein SR, Dambrosia JM, Hallett M. Sensory training for patients with focal hand dystonia. Ann Neurol. 2002 May;51(5):593-8. doi: 10.1002/ana.10174.
- Background: PubMed 14502673Zeuner KE, Hallett M. Sensory training as treatment for focal hand dystonia: a 1-year follow-up. Mov Disord. 2003 Sep;18(9):1044-7. doi: 10.1002/mds.10490.
- Background: PubMed 15486996Zeuner KE, Shill HA, Sohn YH, Molloy FM, Thornton BC, Dambrosia JM, Hallett M. Motor training as treatment in focal hand dystonia. Mov Disord. 2005 Mar;20(3):335-41. doi: 10.1002/mds.20314.
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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.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing BoNT Injections and Occupational Therapy in people with Dystonia, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 8 inclusion and 6 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 20 Mar 2018. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 23 Jan 2018). 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?
Using a Patient Rated Subjective Scale (Visual Analogue Scale), Change From Baseline With Botulinum Toxin Therapy Plus Occupational Therapy Compared to Botulinum Toxin Therapy Alone at 20 Weeks. (time frame: Baseline and 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02015039, which also lists 3 linked publications.
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 20 Mar 2018.