Trial record 5 of 81 for:    Open Studies | "Occupational Therapy"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT02015039
First received: December 13, 2013
Last updated: September 16, 2014
Last verified: November 2013
  Purpose

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.


Condition Intervention Phase
Dystonia
Drug: BoNT Injections
Procedure: Occupational Therapy
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Trial of Botulinum Toxin and Occupational Therapy for Writer's Cramp

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 24 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: December 2013
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: BoNT Injections
    N/A
    Procedure: Occupational Therapy
    N/A
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02015039

Contacts
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
Contact: Mark Hallett, M.D. (301) 496-9526 hallettm@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier: NCT02015039     History of Changes
Other Study ID Numbers: 140030, 14-N-0030
Study First Received: December 13, 2013
Last Updated: September 16, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Occupational Therapy
Botulinum Toxin
Writer's Cramp

Additional relevant MeSH terms:
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014