Cerebellar Deep Brain Stimulation or VNS for Chronic Post-stroke Motor Rehabilitation

NCT06303960 | Recruiting Early Phase 1

• 1 other identifier: VNS or DBS for stroke
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Hemiparesis; Cerebellar Deep Brain Stimulation; VNS; Limb Motor Function Rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (8)

• Arm Motor Ability Test (AMAT) between cerebellar DBS and VNS

  12 months after device implantation

• the Nine-Hole Peg Test between cerebellar DBS and VNS

  12 months after device implantation

• the Bilateral Box and Block Test between cerebellar DBS and VNS

  12 months after device implantation

• Short Form Health Survey (SF-12) between cerebellar DBS and VNS

  12 months after device implantation

• the EuroQol Five Dimensions Questionnaire (EQ-5D) between cerebellar DBS and VNS

  12 months after device implantation

Study Arms (3)

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.

Device: Bilateral Cerebellar deep brain stimulation

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.

Device: Unilateral Cerebellar deep brain stimulation

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.

Device: Vagus Nerve Stimulation

Interventions

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

Bilateral Cerebellar deep brain stimulation

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

Unilateral Cerebellar deep brain stimulation

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.

Vagus Nerve Stimulation

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4)
• Severe cognitive impairment (Mini Mental State Examination \< 24)

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Chao Zhang

Jinan, Shandong, 250100, China

RECRUITING

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 12, 2024
• Study Start: March 15, 2024
• Primary Completion: June 7, 2025
• Study Completion: March 7, 2026
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)