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.
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
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.
- Conditions
- Stroke, Cerebrovascular Accident
- 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 group | Role | What they receive |
|---|---|---|
| Arm 1 | Active comparator | persons with severe hand impairment following hemiparetic stroke Receives: Drug: lidocaine; Device: muscle stimulator |
| Arm 2 | Active comparator | persons 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.
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.
- First posted25 May 2009 (estimated)
- Study startFeb 2009
- Primary completionJan 2013
- Study completionJan 2013
Why it stopped: Methods unexpectedly required additional refinement that precluded subject enrollment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Joseph Towles, Principal investigator, Edward Hines Jr. VA Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Source of Neurally-Mediated Hand Weakness After Stroke
- ClinicalTrials.gov ID
- NCT00907829
- Acronym / sponsor ID
- B6302-W
- Conditions
- Stroke, Cerebrovascular Accident
- Keywords
- stroke, fingertip force, muscle coordination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Methods unexpectedly required additional refinement that precluded subject enrollment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Feb 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 25 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Active comparator | Drug: lidocaine, Device: muscle stimulatorpersons with severe hand impairment following hemiparetic stroke |
| Arm 2 | Active comparator | Device: muscle stimulatorpersons with severe hand impairment following hemiparetic stroke |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| lidocainecomparison of the effect of the drug to help improve finger function | Drug | Arm 1 |
| muscle stimulatorcomparison of the effect of stimulated muscle(s) on finger function | Device | Arm 1, Arm 2 |
Primary outcome
fingertip force
Time frame: force measured before and after intervention (1 week later)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
Related trials for Stroke
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Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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OPTION-EMEA Clinical Trial
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A Study to Test if Tenecteplase Helps People to Recover From an Acute Stroke When Given More Than 4.5 Hours After the Person Was Last Seen Well
Acute Ischemic Stroke
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Stimulation-Temperature-Oxygen-Positioning Multimodal Neuroprotection for Acute Ischemic Stroke (STOP)
Acute Ischemic Stroke
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Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Towles principal investigator
Edward Hines Jr. VA Hospital
1 site in 1 country: see every site and its status.
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.