Cerebrovascular AccidentNCT00056706
Ischemic Nerve Block to Improve Hand Function in Stroke Patients
An observational study of Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will determine whether impaired hand function due to stroke can be improved by blocking nerve impulses to the unaffected arm. Following a stroke, the unaffected side of the brain might negatively influence the affected side. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Cerebrovascular Accident
- What is being tested?
- Transient deafferentation
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Jan 2006
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- We will include patients with thromboembolic non-hemorrhagic hemispheric lesions and with hemorrhagic hemispheric lesions (subcortical in the corticospinal tract, or cortical in motor or somatosensory representations, as documented by CT or MRI) at least 12 months after the stroke. In addition, for the TMS measurements we will include 17 age- and gender-matched control subjects.
- For the GOT task, we will choose subjects who initially had a severe sensory paresis (sensory NIH-SS below 1), which subsequently recovered to the point that they have a residual somatosensory deficit but can perform the task.
- For the motor performance, we will choose subjects who initially had a severe motor paresis (below MRC grade 2), which subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks.
Who cannot join
- Patients with more than one stroke.
- Patients with bilateral motor impairment.
- Patients with cerebellar or brainstem lesions.
- Patients or subjects unable to perform the task (wrist or elbow flexion at least MRC grade 2, less than 75% of performance in the grating orientation task with a grating of 3.0).
- Patients or subjects with history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).
- Patients or subjects with severe uncontrolled medical problems (e.g. cardiovascular disease, severe rheumatoid arthritis, active joint deformity of arthritic origin, active cancer or renal disease, any kind of end-stage pulmonary or cardiovascular disease, or a deteriorated condition due to age, uncontrolled epilepsy or others).
Show all 14Show fewer
- Patients or subjects with increased intracranial pressure as evaluated by clinical means.
- Patients or subjects with unstable cardiac arrhythmia.
- Patients or subjects with history of hyperthyroidism or individuals receiving drugs acting primarily on the central nervous system.
- Patients with more than moderate to severe microangiopathy, polyneuropathy, diabetes mellitus, or ischemic peripheral disease.
- Patients with a history of deep vein thrombosis.
- Patients receiving anticoagulant treatment at the time of the proposed study.
- Excessive callus at the palm of the fingers.
- Pregnancy in women.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Improved Function in the Paretic Hand of Chronic Stroke Patients by Transient Deafferentation of the Intact Upper Extremity
This study will determine whether impaired hand function due to stroke can be improved by blocking nerve impulses to the unaffected arm. Following a stroke, the unaffected side of the brain might negatively influence the affected side. Studies in healthy volunteers show that function in one hand improves when ischemic nerve block (inflating a pressure cuff to block nerve impulses) is applied to the forearm of the other hand. This study will examine whether similar improvement also occurs in the affected hand of patients with chronic impairment after stroke.
Stroke patients with sensory (numbness) or motor impairment (weakness) in the hand that has persisted at least 12 months after the stroke may be eligible for this study. Patients who have had more than one stroke, whose stroke affected both sides of the body, who have a history of deep vein thrombosis (blood clotting), or who are receiving anticoagulant (blood-thinning) treatment at the time of the study will not be enrolled.
Read more
Participants will have physical and neurological examinations and will undergo the following procedures:
Session 1
- Magnetic resonance imaging (if one has not been done within the previous 6 months): MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the patient lies on a table that is moved into the scanner (a narrow cylinder) and wears earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 45 to 90 minutes, during which the patient lies still up to a few minutes at a time.
- Mini Mental State Examination - Patients will take a short test to assess cognitive function.
Sessions 2 (and possibly 3 and 4)
- Motor task practice: Patients practice a motor task several times to achieve optimal performance. The task is a rhythmic, repetitive pinch grip at maximal strength at a frequency of one grip every 10 seconds. If technical difficulties arise during the session, the procedure will be repeated in sessions 3 and 4.
Sessions 5 (and possibly 6)
- Pinch grip and ischemic nerve block (INB): Patients perform the pinch grip task several times and then INB is applied. For INB, a blood pressure cuff is inflated around the arm at the level of the elbow for 35 to 50 minutes. The procedure causes temporary numbness, tingling, loss of muscle strength, and discoloration or the forearm and hand. Patients repeat the pinch grip task during the INB and again 20 minutes after the INB is released. If technical difficulties arise during the session, the procedure will be repeated in session 6.
Session 7
This session is identical to session 5, except the INB is applied immediately above the ankle instead of on the forearm.
Read the detailed description
There are very few therapeutic options for the treatment of disability resulting from chronic stroke. We recently found that transient deafferentation of one hand in healthy subjects enhanced performance in corticomotor excitability and a tactile discriminative task, targeting muscles in the opposite non-deafferented hand. The purpose of this protocol is to test the hypothesis that transient deafferentation of the intact hand in chronic stroke patients will improve functions in the paretic hand. We plan to study patients with chronic strokes dating back at least one year, and either predominantly motor or somatosensory deficits.
Primary outcome measures are (a) in patients with predominantly somatosensory deficit, deafferentation-induced improvement in a tactile discrimination task (grating orientation task GOT and (b) in patients with predominantly motor deficit, deafferentation-induced improvement in pinch muscle strength.
Modified primary outcome measure will be the decrease in interhemispheric inhibition targeting the paretic hand during deafferentation of the healthy hand (chronic stroke patients, motor deficit group).
Secondary outcome measure will be the decrease in interhemispheric inhibition targeting the non-deafferented hand in healthy control subjects.
- Conditions
- Cerebrovascular Accident
- Being tested
- Transient deafferentation
- Keywords
- Motor Deficit, Somatosensory Deficit, Cortical Reorganization, Disinhibition, Rehabilitation, Plasticity, Stroke
- Medical subject headings
- Stroke, Neurologic Manifestations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transient deafferentationProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2003 (estimated)
- Study startMar 2003
- Study completionJan 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cerebrovascular AccidentStudies 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
- Observational
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00056706
- Sponsor's protocol ID
- 030135
- Other IDs
- 03-N-0135
- Status last verified
- Jan 2006
- First submitted
- 21 Mar 2003
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Brasil-Neto JP, Cohen LG, Pascual-Leone A, Jabir FK, Wall RT, Hallett M. Rapid reversible modulation of human motor outputs after transient deafferentation of the forearm: a study with transcranial magnetic stimulation. Neurology. 1992 Jul;42(7):1302-6. doi: 10.1212/wnl.42.7.1302.
PubMed 1620338Calford MB, Tweedale R. Interhemispheric transfer of plasticity in the cerebral cortex. Science. 1990 Aug 17;249(4970):805-7. doi: 10.1126/science.2389146.
PubMed 2389146Chen R, Cohen LG, Hallett M. Nervous system reorganization following injury. Neuroscience. 2002;111(4):761-73. doi: 10.1016/s0306-4522(02)00025-8.
PubMed 12031403
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Function in the Paretic Hand of Chronic Stroke Patients by Transient Deafferentation of the Intact Upper Extremity
- ClinicalTrials.gov ID
- NCT00056706
- Acronym / sponsor ID
- 030135
- Conditions
- Cerebrovascular Accident
- Keywords
- Motor Deficit, Somatosensory Deficit, Cortical Reorganization, Disinhibition, Rehabilitation, Plasticity, Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Mar 2003
- Study completion
- Jan 2006
- First posted
- 20 Mar 2003 (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.
This study will determine whether impaired hand function due to stroke can be improved by blocking nerve impulses to the unaffected arm. Following a stroke, the unaffected side of the brain might negatively influence the affected side. Studies in healthy volunteers show that function in one hand improves when ischemic nerve block (inflating a pressure cuff to block nerve impulses) is applied to the forearm of the other hand. This study will examine whether similar improvement also occurs in the affected hand of patients with chronic impairment after stroke.
Stroke patients with sensory (numbness) or motor impairment (weakness) in the hand that has persisted at least 12 months after the stroke may be eligible for this study. Patients who have had more than one stroke, whose stroke affected both sides of the body, who have a history of deep vein thrombosis (blood clotting), or who are receiving anticoagulant (blood-thinning) treatment at the time of the study will not be enrolled.
Participants will have physical and neurological examinations and will undergo the following procedures:
Session 1
- Magnetic resonance imaging (if one has not been done within the previous 6 months): MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the patient lies on a table that is moved into the scanner (a narrow cylinder) and wears earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. The procedure lasts about 45 to 90 minutes, during which the patient lies still up to a few minutes at a time.
- Mini Mental State Examination - Patients will take a short test to assess cognitive function.
Sessions 2 (and possibly 3 and 4)
- Motor task practice: Patients practice a motor task several times to achieve optimal performance. The task is a rhythmic, repetitive pinch grip at maximal strength at a frequency of one grip every 10 seconds. If technical difficulties arise during the session, the procedure will be repeated in sessions 3 and 4.
Sessions 5 (and possibly 6)
- Pinch grip and ischemic nerve block (INB): Patients perform the pinch grip task several times and then INB is applied. For INB, a blood pressure cuff is inflated around the arm at the level of the elbow for 35 to 50 minutes. The procedure causes temporary numbness, tingling, loss of muscle strength, and discoloration or the forearm and hand. Patients repeat the pinch grip task during the INB and again 20 minutes after the INB is released. If technical difficulties arise during the session, the procedure will be repeated in session 6.
Session 7
This session is identical to session 5, except the INB is applied immediately above the ankle instead of on the forearm.
Detailed description
There are very few therapeutic options for the treatment of disability resulting from chronic stroke. We recently found that transient deafferentation of one hand in healthy subjects enhanced performance in corticomotor excitability and a tactile discriminative task, targeting muscles in the opposite non-deafferented hand. The purpose of this protocol is to test the hypothesis that transient deafferentation of the intact hand in chronic stroke patients will improve functions in the paretic hand. We plan to study patients with chronic strokes dating back at least one year, and either predominantly motor or somatosensory deficits.
Primary outcome measures are (a) in patients with predominantly somatosensory deficit, deafferentation-induced improvement in a tactile discrimination task (grating orientation task GOT and (b) in patients with predominantly motor deficit, deafferentation-induced improvement in pinch muscle strength.
Modified primary outcome measure will be the decrease in interhemispheric inhibition targeting the paretic hand during deafferentation of the healthy hand (chronic stroke patients, motor deficit group).
Secondary outcome measure will be the decrease in interhemispheric inhibition targeting the non-deafferented hand in healthy control subjects.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- We will include patients with thromboembolic non-hemorrhagic hemispheric lesions and with hemorrhagic hemispheric lesions (subcortical in the corticospinal tract, or cortical in motor or somatosensory representations, as documented by CT or MRI) at least 12 months after the stroke. In addition, for the TMS measurements we will include 17 age- and gender-matched control subjects.
- For the GOT task, we will choose subjects who initially had a severe sensory paresis (sensory NIH-SS below 1), which subsequently recovered to the point that they have a residual somatosensory deficit but can perform the task.
- For the motor performance, we will choose subjects who initially had a severe motor paresis (below MRC grade 2), which subsequently recovered to the point that they have a residual motor deficit but can perform the required tasks.
Key exclusion criteria (14 listed)
- Patients with more than one stroke.
- Patients with bilateral motor impairment.
- Patients with cerebellar or brainstem lesions.
- Patients or subjects unable to perform the task (wrist or elbow flexion at least MRC grade 2, less than 75% of performance in the grating orientation task with a grating of 3.0).
- Patients or subjects with history of severe alcohol or drug abuse, psychiatric illness like severe depression, poor motivational capacity, or severe language disturbances, particularly of receptive nature or with serious cognitive deficits (defined as equivalent to a mini-mental state exam score of 23 or less).
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 |
|---|---|---|
| Transient deafferentation | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 1620338Brasil-Neto JP, Cohen LG, Pascual-Leone A, Jabir FK, Wall RT, Hallett M. Rapid reversible modulation of human motor outputs after transient deafferentation of the forearm: a study with transcranial magnetic stimulation. Neurology. 1992 Jul;42(7):1302-6. doi: 10.1212/wnl.42.7.1302.
- Background: PubMed 2389146Calford MB, Tweedale R. Interhemispheric transfer of plasticity in the cerebral cortex. Science. 1990 Aug 17;249(4970):805-7. doi: 10.1126/science.2389146.
- Background: PubMed 12031403Chen R, Cohen LG, Hallett M. Nervous system reorganization following injury. Neuroscience. 2002;111(4):761-73. doi: 10.1016/s0306-4522(02)00025-8.
Related trials for Cerebrovascular Accident
RecruitingPhase 1/2
Safety and Efficacy of CG-BM1 in Ischemic Stroke
Ischemic Stroke or High-risk TIA (ABCD² ≥ 4)
Not yet recruitingPhase 3
Recombinant Human Prourokinase for Acute Ischemic Stroke in the Extended Window Selected by CT-Based Artificial Intelligence
Acute Ischemic Stroke
Recruiting
Effects of Mirror Therapy and Motor Imagery on Upper Limb Motor Functions in Middle Cerebral Artery Stroke
Stroke
Recruiting
Rapid Local Ischemic Postconditioning on Stroke After Thrombectomy
Acute Ischemic Stroke
Not yet recruitingObservational study
The GEIR Registry: Rationale and Design of the First Nationwide Multicentre Retinal Stroke Registry in Spain
Retinal Artery Occlusion
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 3 inclusion and 14 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: finished, as of the sponsor's last update on 4 Mar 2008. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00056706, which also lists 3 linked publications.
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 4 Mar 2008.