Pilot Trial of Botulinum Toxin and Occupational Therapy for Writer's Cramp

NCT02015039 | Completed Phase 1 Results

• 2 other identifiers: 14003014-N-0030
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Dystonia

Keywords

Occupational Therapy; Botulinum Toxin; Writer's Cramp

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline and 20 weeks

• Change on the Writer's Cramp Impairment Scale (WCIS) Score From Baseline to 20 Weeks.

  Baseline and 20 weeks

• Change on the Writer's Cramp Disability Scale (WCDS) Score From Baseline to 20 Weeks.

  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.

  Baseline and 20 weeks

• Change in Quantitative Writing Metrics Obtained Via Numerical Analyses of Writing Samples Using a Digitizing Tablet.

  Baseline and 20 weeks

Study Arms (2)

Botulinum Toxin Therapy Only

ACTIVE COMPARATOR

Drug: BoNT Injections

Botulinum Toxin Therapy plus Occupational Therapy

EXPERIMENTAL

Intervention

Drug: BoNT Injections; Procedure: Occupational Therapy

Interventions

BoNT Injections DRUG

Botulinum Toxin Therapy Only; Botulinum Toxin Therapy plus Occupational Therapy

Occupational Therapy PROCEDURE

Botulinum Toxin Therapy plus Occupational Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 12112105 BACKGROUND

• 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.

  PMID: 14502673 BACKGROUND

• 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.

  PMID: 15486996 BACKGROUND

MeSH Terms

Conditions

Dystonia; Dystonic Disorders

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Movement Disorders; Central Nervous System Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Results Point of Contact

• Title: Dr. Mark Hallett
• Organization: National Institutes of Health

hallettm@ninds.nih.gov

301-496-9526

Study Officials

• Mark Hallett, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2013
• First Posted: December 19, 2013
• Study Start: December 3, 2013
• Primary Completion: September 13, 2016
• Study Completion: September 13, 2016
• Last Updated: March 20, 2018
• Results First Posted: January 23, 2018

Record last verified: 2018-02-13

Locations

US (1)