Source of Hand Weakness After Stroke

NCT ID: NCT00907829

Last Updated: 2014-05-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2013-01-31

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.

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.

Conditions

Stroke; Cerebrovascular Accident

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Arm 1

persons with severe hand impairment following hemiparetic stroke

Group Type: ACTIVE_COMPARATOR

lidocaine

Intervention Type: DRUG

comparison of the effect of the drug to help improve finger function

muscle stimulator

Intervention Type: DEVICE

comparison of the effect of stimulated muscle(s) on finger function

Arm 2

persons with severe hand impairment following hemiparetic stroke

Group Type: ACTIVE_COMPARATOR

muscle stimulator

Intervention Type: DEVICE

comparison of the effect of stimulated muscle(s) on finger function

Interventions

lidocaine

comparison of the effect of the drug to help improve finger function

Intervention Type: DRUG

muscle stimulator

comparison of the effect of stimulated muscle(s) on finger function

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Joseph Towles

Role: PRINCIPAL_INVESTIGATOR

Edward Hines Jr. VA Hospital

Locations

Edward Hines, Jr. VA Hospital

Hines, Illinois, United States

Countries

United States

Other Identifiers

B6302-W

Identifier Type: -

Identifier Source: org_study_id