Clinical trial NCT02015039: Pilot Trial of Botulinum Toxin and Occupational Therapy for Writer's Cramp
Official title: Pilot Trial of Botulinum Toxin and Occupational Therapy for Writer's Cramp
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dystonia
Keywords: Occupational Therapy
Botulinum Toxin
Writer's Cramp
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2013-12-19
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: * INCLUSION CRITERIA

  1. be at least 18 years of age
  2. have writer s cramp
  3. patients are enrolled in 93-N-0202 and 85-N-0195
  4. willing to be videotaped while writing
  5. have normal hand function other than FHD
  6. be willing to use therapeutic daily rehabilitative therapies as prescribed
  7. have some positive subjective response to BoNT demonstrated on at least two prior treatments
  8. be able to comprehend and perform the daily activities required for those who are involved in combined therapy.

EXCLUSION CRITERIA

1. BoNT administration within 3 months of participation
2. No response to BoNT
3. Unable to provide consent
4. Patients taking oral medications for WC including muscle relaxants or other centrally-active medications such as antidepressants which may enhance tremors
5. Medical conditions that affect hand function, such as stroke, nerve entrapment, tremor, parkinsonism, chorea, ataxia affecting the dominant hand
6. Unable to provide consent

Primary outcomes:
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.
timeFrame: Baseline and 20 weeks
Secondary outcomes:
measure: 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.
timeFrame: Baseline and 20 weeks
measure: Change on the Writer's Cramp Impairment Scale (WCIS) Score From Baseline to 20 Weeks.
timeFrame: Baseline and 20 weeks
measure: Change on the Writer's Cramp Disability Scale (WCDS) Score From Baseline to 20 Weeks.
timeFrame: Baseline and 20 weeks
measure: Change in Hand Grip Strength From Baseline to 20 Weeks Following Botulinum Toxin Therapy Alone and Botulinum Toxin Therapy Plus Occupational Therapy.
timeFrame: Baseline and 20 weeks
measure: Change in Quantitative Writing Metrics Obtained Via Numerical Analyses of Writing Samples Using a Digitizing Tablet.
timeFrame: Baseline and 20 weeks
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 24 Weeks.
timeFrame: Baseline and 24 weeks
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
name: Mark Hallett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Zeuner 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.
citation: Zeuner 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.