Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00056706
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2003-03-21
Brief Title:
Ischemic Nerve Block to Improve Hand Function in Stroke Patients
Sponsor:
National Institute of Neurological Disorders and Stroke NINDS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Improved Function in the Paretic Hand of Chronic Stroke Patients by Transient Deafferentation of the Intact Upper Extremity
Status:
COMPLETED
Status Verified Date:
2006-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 03-N-0135 | None | None | None |