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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06303960
• Other study ID #: Cerebellar DBS for stroke
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 15, 2024
• Est. completion date: March 7, 2026

Study information

• Verified date: February 2024
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. We hypothesized that bilateral stimulation was superior to unilateral stimulation as the motor rehabilitation after stroke benefits from both side of cerebellum.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 7, 2026
• Est. primary completion date: March 7, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• Bilateral 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
• Unilateral 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

Locations

Country	Name	City	State
China	Chao Zhang	Jinan	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	safety and feasibility of bilateral cerebellar DBS	The incidence of adverse events including hemorrhages, infections, deaths or major perioperative complications during the study	12 months after DBS
Secondary	FM-UE scores between bilateral and unilateral cerebellar DBS	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 DBS
Secondary	Arm Motor Ability Test (AMAT) bilateral and unilateral cerebellar DBS	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 DBS
Secondary	the Nine-Hole Peg Test between bilateral and unilateral cerebellar DBS	The outcomes includes each participant's the Nine-Hole Peg Test for each monthly visit.	12 months after DBS
Secondary	the Bilateral Box and Block Test between bilateral and unilateral cerebellar DBS	The outcomes includes each participant's the Bilateral Box and Block Test for each monthly visit.	12 months after DBS
Secondary	Short Form Health Survey (SF-12) between bilateral and unilateral cerebellar DBS	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 DBS
Secondary	the EuroQol Five Dimensions Questionnaire (EQ-5D) between bilateral and unilateral cerebellar DBS	The outcomes includes each participant's score of the EuroQol (EQ-5D) for each monthly visit.	12 months after DBS
Secondary	the Beck Depression Inventory or the Beck Anxiety Inventory between bilateral and unilateral cerebellar DBS	The outcomes includes each participant's score of the Beck Depression Inventory or the Beck Anxiety Inventory for each monthly visit.	12 months after DBS
Secondary	nerve conduction velocity between bilateral and unilateral cerebellar DBS	The outcomes includes each participant's nerve conduction velocity for each monthly visit recorded by flexible electrode.	12 months after DBS