Stroke
Conditions
Keywords
Hemiparesis, Cerebellar Deep Brain Stimulation, VNS, Limb Motor Function Rehabilitation
Brief summary
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.
Interventions
DEVICEBilateral Cerebellar deep brain stimulation
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
DEVICEUnilateral Cerebellar deep brain stimulation
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
DEVICEVagus Nerve Stimulation
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.
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 12-36 months before surgery. * Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42 * Sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension).
Exclusion criteria
* Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4) * Severe cognitive impairment (Mini Mental State Examination \< 24)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FM-UE scores between cerebellar DBS and VNS | 12 months after device implantation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the Nine-Hole Peg Test between cerebellar DBS and VNS | 12 months after device implantation | The outcomes includes each participant's the Nine-Hole Peg Test for each monthly visit. |
| the Bilateral Box and Block Test between cerebellar DBS and VNS | 12 months after device implantation | The outcomes includes each participant's the Bilateral Box and Block Test for each monthly visit. |
| Short Form Health Survey (SF-12) between cerebellar DBS and VNS | 12 months after device implantation | 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. |
| Arm Motor Ability Test (AMAT) between cerebellar DBS and VNS | 12 months after device implantation | 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. |
| the Beck Depression Inventory or the Beck Anxiety Inventory between cerebellar DBS and VNS | 12 months after device implantation | The outcomes includes each participant's score of the Beck Depression Inventory or the Beck Anxiety Inventory for each monthly visit. |
| nerve conduction velocity between cerebellar DBS and VNS | 12 months after device implantation | The outcomes includes each participant's nerve conduction velocity for each monthly visit recorded by flexible electrode. |
| safety and feasibility of VNS and cerebellar DBS | 12 months after device implantation | The incidence of adverse events including hemorrhages, infections, deaths or major perioperative complications during the study |
| the EuroQol Five Dimensions Questionnaire (EQ-5D) between cerebellar DBS and VNS | 12 months after device implantation | The outcomes includes each participant's score of the EuroQol (EQ-5D) scores range from 0 to 36 for each monthly visit. |
Countries
China
Outcome results
None listed