Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Source of Hand Weakness After Stroke

This study has been withdrawn prior to enrollment.
(Methods unexpectedly required additional refinement that precluded subject enrollment.)
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00907829
First received: May 21, 2009
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to determine whether neural block and neuromuscular electrical stimulation are effective in treating finger impairment due to stroke.


Condition Intervention Phase
Stroke
Cerebrovascular Accident
Drug: lidocaine
Device: muscle stimulator
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Source of Neurally-Mediated Hand Weakness After Stroke

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • fingertip force [ Time Frame: force measured before and after intervention (1 week later) ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2009
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
persons with severe hand impairment following hemiparetic stroke
Drug: lidocaine
comparison of the effect of the drug to help improve finger function
Device: muscle stimulator
comparison of the effect of stimulated muscle(s) on finger function
Active Comparator: Arm 2
persons with severe hand impairment following hemiparetic stroke
Device: muscle stimulator
comparison of the effect of stimulated muscle(s) on finger function

Detailed Description:

The incidence of stroke-induced hemiparesis among veterans is likely to rise as this population ages. Post-stroke hemiparesis is often marked by persistent hand impairment, which adversely affects both a person's ability to work and his/her quality of life. We believe that impairment is primarily due to neural, rather than biomechanical, factors. At the muscle level, these factors relate either to the inability to activate muscles (i.e., low muscle activation) or to activate them appropriately (i.e., abnormal muscle co-activation). Currently it is unclear as to which one is largely responsible for weakness in the hand as the net mechanical effect, e.g., reduced fingertip force production, could be the same. Determination of voluntary muscle force generation could help to explain deficits in fingertip force production in specific directions, as well as to customize treatment approaches in which force generation ability of some muscles is decreased and others increased. The goal of this work is to explain the source of neurally-mediated weakness at the fingertip following hemiparetic stroke, and to design and experimentally test rehabilitation interventions that attempt to offset this weakness.

As we were refining the protocol to experimentally test a rehabilitation intervention—involving neural block and stimulation of select muscles to decrease and increase muscle force generation—it was more challenging than anticipated to locate, using ultrasound, small nerve branches to individual muscles for selective neural blocking. As a result we designed additional interventions, using a computer model, that reflected the physical limitation to implementation which could still hopefully lead to improved fingertip function. We are seeking novel approaches to locate and block small nerve branches to individual muscles for an individual muscle-based approach to rehabilitation which we expect to be an improvement over rehabilitation interventions that target groups of muscles at a time. The clinical data collected in the study and biomechanical model simulation work provide guidance for a clinical trial study in the future.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis of stroke;
  • stroke occurred no less than 6 months prior to study;
  • must have had only 1 stroke;
  • must demonstrate severe hand impairment;
  • must have no substantial evidence of motor and sensory deficits in non-paretic limb;
  • must have no history or clinical signs of neurologic diseases other than stroke;
  • must have no cognitive dysfunction that precludes comprehension of experimental tasks;
  • must be able to give informed consent

Exclusion Criteria:

  • taking medication that can increase the risk of lidocaine toxicity such as cimetidine (ulcer treatment drug), phenytoin (anticonvulsant drug), nadolol (drug for treatment of headache, hypertension, chest pain);
  • taking anticoagulant medication, i.e., aspirin, coumadin;
  • has a low platelet count or a bleeding disease
  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: NCT00907829

Locations
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
Investigators
Principal Investigator: Joseph Towles Edward Hines Jr. VA Hospital
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00907829     History of Changes
Other Study ID Numbers: B6302-W
Study First Received: May 21, 2009
Last Updated: May 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
stroke
fingertip force
muscle coordination

Additional relevant MeSH terms:
Cerebral Infarction
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 27, 2014