StrokeEarly Phase 1NCT06303960
Cerebellar Deep Brain Stimulation or VNS for Chronic Post-stroke Motor Rehabilitation
A Early Phase 1 study testing Bilateral Cerebellar deep brain stimulation, Unilateral Cerebellar deep brain stimulation and Vagus Nerve Stimulation in people with Stroke, run by Qilu Hospital of Shandong University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 30 to 75 years
- Conditions the study is for
- Stroke
- What is being tested?
- Bilateral Cerebellar deep brain stimulation, Unilateral Cerebellar deep brain stimulation and Vagus Nerve Stimulation
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2024to 7 Mar 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4)
- Severe cognitive impairment (Mini Mental State Examination < 24)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Chao Zhang
Jinan, Shandong, 250100
chao zhang, +8613969007232, chao_zhang@sdu.edu.cn
About this study
Official title: The Comparison of Treatment Results Between Cerebellar DBS and Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial
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
- Being tested
- Bilateral Cerebellar deep brain stimulation, Unilateral Cerebellar deep brain stimulation, Vagus Nerve Stimulation
- Keywords
- Hemiparesis, Cerebellar Deep Brain Stimulation, VNS, Limb Motor Function Rehabilitation
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bilateral Cerebellar deep brain stimulationDevice
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 stimulationDevice
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 StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Device: Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months after device implantation
Secondary outcomes (8)
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.
Measured: 12 months after device implantation
the Nine-Hole Peg Test between cerebellar DBS and VNS
The outcomes includes each participant's the Nine-Hole Peg Test for each monthly visit.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 months after device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 Mar 2024
- Primary completion7 Jun 2025 (estimated)
- Study completion7 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303960
- Sponsor's protocol ID
- VNS or DBS for stroke
- Status last verified
- Apr 2025
- First submitted
- 5 Feb 2024
- Last updated
- 17 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) could be available to other researchers by request of email
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Comparison of Treatment Results Between Cerebellar DBS and Vagus Stimulation for Post-stroke Motor Rehabilitation: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06303960
- Acronym / sponsor ID
- VNS or DBS for stroke
- Conditions
- Stroke
- Keywords
- Hemiparesis, Cerebellar Deep Brain Stimulation, VNS, Limb Motor Function Rehabilitation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 15 Mar 2024 (actual)
- Primary completion
- 7 Jun 2025 (estimated)
- Study completion
- 7 Mar 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bilateral Cerebellar deep brain stimulation | Active comparator | Device: Bilateral Cerebellar deep brain stimulationFollowing 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. |
| Unilateral Cerebellar deep brain stimulation | Active comparator | Device: Unilateral Cerebellar deep brain stimulationFollowing 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. |
| Vagus Nerve Stimulation | Experimental | Device: Vagus Nerve StimulationFollowing 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4)
- Severe cognitive impairment (Mini Mental State Examination < 24)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bilateral Cerebellar deep brain stimulationParticipants 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 | Device | Bilateral Cerebellar deep brain stimulation |
| Unilateral Cerebellar deep brain stimulationParticipants 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 | Device | Unilateral Cerebellar deep brain stimulation |
| Vagus Nerve StimulationDevice 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. | Device | Vagus Nerve Stimulation |
Primary outcome
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.
8 secondary outcomes
Arm Motor Ability Test (AMAT) between cerebellar DBS and VNS
Time frame: 12 months after device implantation
the Nine-Hole Peg Test between cerebellar DBS and VNS
Time frame: 12 months after device implantation
the Bilateral Box and Block Test between cerebellar DBS and VNS
Time frame: 12 months after device implantation
Short Form Health Survey (SF-12) between cerebellar DBS and VNS
Time frame: 12 months after device implantation
the EuroQol Five Dimensions Questionnaire (EQ-5D) between cerebellar DBS and VNS
Time frame: 12 months after device implantation
the Beck Depression Inventory or the Beck Anxiety Inventory between cerebellar DBS and VNS
Time frame: 12 months after device implantation
nerve conduction velocity between cerebellar DBS and VNS
Time frame: 12 months after device implantation
safety and feasibility of VNS and cerebellar DBS
Time frame: 12 months after device implantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) could be available to other researchers by request of email
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bilateral Cerebellar deep brain stimulation, Unilateral Cerebellar deep brain stimulation and Vagus Nerve Stimulation in people with Stroke, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FM-UE scores between cerebellar DBS and VNS (time frame: 12 months after device implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.