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StrokePhase 2NCT00907829

Source of Hand Weakness After Stroke

A Phase 2 study testing lidocaine and muscle stimulator in people with Stroke and Cerebrovascular Accident, run by US Department of Veterans Affairs at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 80 years
Conditions the study is for
Stroke, Cerebrovascular Accident
What is being tested?
lidocaine and muscle stimulator
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
Feb 2009to Jan 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Edward Hines, Jr. VA Hospital

    Hines, Illinois, 60141-5000

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
lidocaine, muscle stimulator
Keywords
stroke, fingertip force, muscle coordination
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • lidocaineDrug

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

  • muscle stimulatorDevice

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

Study groups in NCT00907829
Study groupRoleWhat they receive
Arm 1Active comparatorpersons with severe hand impairment following hemiparetic stroke
Receives: Drug: lidocaine; Device: muscle stimulator
Arm 2Active comparatorpersons with severe hand impairment following hemiparetic stroke
Receives: Device: muscle stimulator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. fingertip force

    Measured: force measured before and after intervention (1 week later)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionJan 2013
  4. Study completionJan 2013

Why it stopped: Methods unexpectedly required additional refinement that precluded subject enrollment.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00907829
Sponsor's protocol ID
B6302-W
Status last verified
May 2014
First submitted
21 May 2009
Last updated
5 May 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing lidocaine and muscle stimulator in people with Stroke and Cerebrovascular Accident, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

fingertip force (time frame: force measured before and after intervention (1 week later)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2014; AzTrials last refreshed its copy on 28 Oct 2026.

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