Clinical trial NCT00907829: Source of Hand Weakness After Stroke
Official title: Source of Neurally-Mediated Hand Weakness After Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Stroke
Cerebrovascular Accident
Keywords: stroke
fingertip force
muscle coordination
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2009-05-25
Enrollment: 0
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: fingertip force
timeFrame: force measured before and after intervention (1 week later)
Secondary outcomes:
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
Study officials:
affiliation: Edward Hines Jr. VA Hospital
name: Joseph Towles
role: PRINCIPAL_INVESTIGATOR
References: