Ischemic Nerve Block to Improve Hand Function in Stroke Patients
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|ClinicalTrials.gov Identifier: NCT00056706|
Recruitment Status : Completed
First Posted : March 20, 2003
Last Update Posted : March 4, 2008
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:
- 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.
This session is identical to session 5, except the INB is applied immediately above the ankle instead of on the forearm.
|Condition or disease||Intervention/treatment|
|Cerebrovascular Accident||Procedure: Transient deafferentation|
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 Type :||Observational|
|Enrollment :||75 participants|
|Official Title:||Improved Function in the Paretic Hand of Chronic Stroke Patients by Transient Deafferentation of the Intact Upper Extremity|
|Study Start Date :||March 2003|
|Study Completion Date :||January 2006|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00056706
|United States, Maryland|
|National Institute of Neurological Disorders and Stroke (NINDS)|
|Bethesda, Maryland, United States, 20892|