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Upper-extremity impairment after stroke remains a major therapeutic challenge and a target of neuromodulation treatment efforts.In this open-label, randomized phase I trial, we applied deep brain stimulation to the cerebellar dentate nucleus combined with bilateral or unilateral stimulation. Vagus nerve stimulation was also conducted for motor function after ischaemic Stroke.We hypothesized that cerebellar stimulation was superior to vagus stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bilateral Cerebellar deep brain stimulation | Active Comparator | Following enrollment, participants underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the DBS system, with the lead implanted in the DN contralateral to the stroke-affected cerebral hemisphere. 1 months later, DBS was activated bilaterally. |
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| Unilateral Cerebellar deep brain stimulation | Active Comparator | Following enrollment, participants underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the DBS system, with the lead implanted in the DN contralateral to the stroke-affected cerebral hemisphere. 1 months later, DBS was activated unilaterally. |
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| Vagus Nerve Stimulation | Experimental | Following enrollment, participants underwent 1 month of upper-extremity rehabilitation twice per week to rule out potential for recovery with rehabilitation therapy alone. Thereafter, each participant underwent surgical implantation of the VNS system. 1 months later, VNS was activated unilaterally. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Cerebellar deep brain stimulation | Device | Participants underwent stereotactic implantation of a single DBS lead in the area of the cerebellar DN contralateral to the lesioned cerebral hemisphere using a frame-based technique similar to that used in DBS for movement disorders. All participants received an 4-channel lead (Medtronic,3389)with electrode arrays up to 15.5 mm in length. Then bilateral stimulation was activated after 1 month post-DBS |
| Measure | Description | Time Frame |
|---|---|---|
| FM-UE scores between cerebellar DBS and VNS | The outcomes includes each participant's Fugl-Meyer assessment scale (FM-UE) scores for each monthly visit. FM-UE scores range from 0 to 100 and the higher scores indicated better outcome of movement. | 12 months after device implantation |
| Measure | Description | Time Frame |
|---|---|---|
| Arm Motor Ability Test (AMAT) between cerebellar DBS and VNS | The outcomes includes each participant's the Arm Motor Ability Test (AMAT) for each monthly visit. AMAT scores range from 0 to 57 and the higher scores indicated better outcome of movement. | 12 months after device implantation |
| the Nine-Hole Peg Test between cerebellar DBS and VNS |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Zhang | Recruiting | Jinan | Shandong | 250100 | China |
Individual participant data (IPD) could be available to other researchers by request of email
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D055536 | Vagus Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
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|
| Unilateral Cerebellar deep brain stimulation | Device | Participants underwent stereotactic implantation of a single DBS lead in the area of the cerebellar DN contralateral to the lesioned cerebral hemisphere using a frame-based technique similar to that used in DBS for movement disorders. All participants received an 4-channel lead (Medtronic,3389)with electrode arrays up to 15.5 mm in length. Then unilateral stimulation was activated after 1 month post-DBS |
|
| Vagus Nerve Stimulation | Device | Device implantation was done under general anaesthesia. A horizontal neck crease incision was created left of the midline at the level of the cricoid cartilage. After the vagus nerve was identified, the stimulation lead was wrapped around the vagus nerve. The lead was then tunnelled subcutaneously to the pulse generator device which was contained in a subcutaneous pocket in the pectoral region. |
|
The outcomes includes each participant's the Nine-Hole Peg Test for each monthly visit. |
| 12 months after device implantation |
| the Bilateral Box and Block Test between cerebellar DBS and VNS | The outcomes includes each participant's the Bilateral Box and Block Test for each monthly visit. | 12 months after device implantation |
| Short Form Health Survey (SF-12) between cerebellar DBS and VNS | The outcomes includes each participant's score of Short Form Health Survey (SF-12) for each monthly visit. SF-12 scores range from 0 to 60 and the higher scores indicated better outcome of movement. | 12 months after device implantation |
| the EuroQol Five Dimensions Questionnaire (EQ-5D) between cerebellar DBS and VNS | The outcomes includes each participant's score of the EuroQol (EQ-5D) scores range from 0 to 36 for each monthly visit. | 12 months after device implantation |
| the Beck Depression Inventory or the Beck Anxiety Inventory between cerebellar DBS and VNS | The outcomes includes each participant's score of the Beck Depression Inventory or the Beck Anxiety Inventory for each monthly visit. | 12 months after device implantation |
| nerve conduction velocity between cerebellar DBS and VNS | The outcomes includes each participant's nerve conduction velocity for each monthly visit recorded by flexible electrode. | 12 months after device implantation |
| safety and feasibility of VNS and cerebellar DBS | The incidence of adverse events including hemorrhages, infections, deaths or major perioperative complications during the study | 12 months after device implantation |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |