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

Completed · Phase 1/Phase 2

Conditions studied: Dystonia

In brief

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.

Key facts

Study ID

NCT02015039

Run by

National Institute of Neurological Disorders and Stroke (NINDS)

People needed

13

Starts

2013-12-03

Expected to finish

2016-09-13

Last updated by the study team

2018-03-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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