COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Source of Hand Weakness After Stroke

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00907829
Recruitment Status : Withdrawn (Methods unexpectedly required additional refinement that precluded subject enrollment.)
First Posted : May 25, 2009
Last Update Posted : May 5, 2014
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Brief Summary:
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 or disease Intervention/treatment Phase
Stroke Cerebrovascular Accident Drug: lidocaine Device: muscle stimulator Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Source of Neurally-Mediated Hand Weakness After Stroke
Study Start Date : February 2009
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Lidocaine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. fingertip force [ Time Frame: force measured before and after intervention (1 week later) ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00907829

Layout table for location information
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
Sponsors and Collaborators
US Department of Veterans Affairs
Layout table for investigator information
Principal Investigator: Joseph Towles Edward Hines Jr. VA Hospital
Layout table for additonal information
Responsible Party: US Department of Veterans Affairs Identifier: NCT00907829    
Other Study ID Numbers: B6302-W
First Posted: May 25, 2009    Key Record Dates
Last Update Posted: May 5, 2014
Last Verified: May 2014
Keywords provided by VA Office of Research and Development ( US Department of Veterans Affairs ):
fingertip force
muscle coordination
Additional relevant MeSH terms:
Layout table for MeSH terms
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action