Source of Hand Weakness After Stroke

Source of Neurally-Mediated Hand Weakness After Stroke

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

Study Overview

• Status: Withdrawn
• Conditions: Stroke; Cerebrovascular Accident
• Intervention / Treatment: Drug: lidocaine; Device: muscle stimulator

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.

• Study Type: Interventional
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Hines, Illinois, United States, 60141-5000
      • Edward Hines, Jr. VA Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
fingertip force	force measured before and after intervention (1 week later)

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Joseph Towles, Edward Hines Jr. VA Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): January 1, 2013

Study Registration Dates

• First Submitted: May 21, 2009
• First Submitted That Met QC Criteria: May 22, 2009
• First Posted (ESTIMATE): May 25, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 5, 2014
• Last Update Submitted That Met QC Criteria: May 1, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: stroke; fingertip force; muscle coordination
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: B6302-W