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NCT Number: NCT06303960

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

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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Key information

Conditions

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

Age range

30 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

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.

Primary outcomes

  1. FM-UE scores between cerebellar DBS and VNS

    Time frame: 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 outcomes

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

    Time frame: 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.

  2. the Nine-Hole Peg Test between cerebellar DBS and VNS

    Time frame: 12 months after device implantation

    The outcomes includes each participant's the Nine-Hole Peg Test for each monthly visit.

  3. the Bilateral Box and Block Test between cerebellar DBS and VNS

    Time frame: 12 months after device implantation

    The outcomes includes each participant's the Bilateral Box and Block Test for each monthly visit.

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

    Time frame: 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.

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

    Time frame: 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.

  6. the Beck Depression Inventory or the Beck Anxiety Inventory between cerebellar DBS and VNS

    Time frame: 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.

  7. nerve conduction velocity between cerebellar DBS and VNS

    Time frame: 12 months after device implantation

    The outcomes includes each participant's nerve conduction velocity for each monthly visit recorded by flexible electrode.

  8. safety and feasibility of VNS and cerebellar DBS

    Time frame: 12 months after device implantation

    The incidence of adverse events including hemorrhages, infections, deaths or major perioperative complications during the study

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

The Comparison of Treatment Results Between Cerebellar DBS and Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 12, 2024
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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