Deep Brain Stimulation of the Dentate Nucleus for Motor Rehabilitation After Stroke

NCT06498934 | Not Yet Recruiting DMC

• 1 other identifier: HX-A-2024030
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if deep brain stimulation of the dentate nucleus (DN-DBS) works to promote chronic post-stroke upper limb motor function in adults. It will also learn about the safety of DN-DBS. The main questions it aims to answer are: Does DN-DBS paired with rehabilitation improve the upper limb motor function of participants more than rehabilitation only? What medical problems do participants have when using DN-DBS for post-stroke rehabilitation? Researchers will compare real DN-DBS+rehabilitation to sham DN-DBS+rehabilitation (electrodes will be implanted, but no electrical current is given) to see if DN-DBS works to promote chronic post-stroke upper limb motor function. Participants will: Undergo unilateral DN-DBS surgery Take real DN-DBS+rehabilitation or sham DN-DBS+rehabilitation as treatment for 6 months Visit the clinic every month during the DN-DBS+rehabilitation (treatment) period for programing, checkups and tests Visit the clinic at Day 1, 30, 90 and 365 after treatment period for checkups and tests

Conditions

Stroke; Upper Extremity Paresis

Keywords

deep brain stimulation; the dentate nucleus

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change at Day 1

  The Fugl-Meyer Assessment, Upper Limb (FMA-UE) was analyzed for difference in average change at Day-1 after 6-months of therapy compared to baseline (Difference in average change in FMA-UE from baseline \[V0\] to one day after therapy \[V6\]). FMA-UE was collected at each visit. The FMA-UE is a common scale used to measure motor impairment after a stroke. The range is 0 (more impairment) to 66 (no impairment).

  V6, One day after 6-months of therapy

Secondary Outcomes (5)

• Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change at Day 90

  V8, 90 days after 6-months of therapy

• Wolf Motor Function Test (WMFT) Average Change at Day 1

  V6, One day after 6-months of therapy

• Wolf Motor Function Test (WMFT) Average Change at Day 90

  V8, 90 days after 6-months of therapy

• Action Research Arm Test (ARAT) Average Change at Day 1

  V6, One day after 6-months of therapy

• Action Research Arm Test (ARAT) Average Change at Day 90

  V8, 90 days after 6-months of therapy

Study Arms (2)

real DN-DBS + rehabilitation

EXPERIMENTAL

Study treatment is deep brain stimulation of the dentate nucleus (DN-DBS) delivered during 6-month rehabilitation period.

Device: deep brain stimulation; Other: Rehabilitation

sham DN-DBS + rehabilitation

ACTIVE COMPARATOR

Active control treatment is rehabilitation (standard-of-care treatment) with sham DN-DBS (electrode implanted but won't turn on the device).

Other: Rehabilitation

Interventions

deep brain stimulation DEVICE

Stimulation of the dentate nucleus that is paired with upper limb rehabilitation movements.

real DN-DBS + rehabilitation

Rehabilitation OTHER

Rehabilitation movements to improve upper limb function after stroke

real DN-DBS + rehabilitation; sham DN-DBS + rehabilitation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Within the first year to 3 years after the first stroke;
• Unilateral infarction located in the territory of the middle cerebral artery, but not involving the cerebellum, thalamus, and brainstem;
• Aged 18-80 years;
• TMS standard: TMS induces muscle evoked potential (MEP). In the contracted state of the paralyzed muscle (maximum voluntary contraction of 20-50%), a reliable standard MEP (in 5/10 trials with 50-100uv) can be induced;
• Researchers determine the medical and neurological condition of the participant to be stable based on the participant's medical history, physical examination, and neurological examination;
• Moderate-severe unilateral upper limb paralysis, i.e., the Fugl-Meyer Assessment (FMA-UE) scale score is ≤47;
• The distal extremity of the limb has some degree of motor function (flexion of the elbow joint or extension of the elbow joint or partial finger flexion with FMA-UE ≥1);
• mRS\<4 points, able to cooperate with assessment and rehabilitation;
• No spasticity or mild spasticity in any part of the affected limb (intramuscular rotator muscle and adductor muscle of the shoulder joint, flexor muscle of the elbow joint, flexor muscle of the wrist joint or finger flexor muscle), modified Ashworth scale (MAS) \<4 points;
• MMSE\>24 points.

You may not qualify if:

• Primary hemorrhagic stroke or severe hemorrhagic conversion;
• Any progressive neurological or somatic disease that impairs the function of the affected limb other than stroke;
• Moderate to severe neglect or disinhibition of the affected limb;
• Any other neurological disorder that may compromise study safety, including central nervous system vasculitis, intracranial tumors, intracranial aneurysms, multiple sclerosis, or arteriovenous malformations;
• Pain intensity on the affected limb NRS ≥5 or severe sensory disturbance, NIHSS (item 8) = 2;
• Unable to stop anticoagulation treatment at least 10 days prior to surgery (i.e., antiplatelet and/or anticoagulant therapy);
• Seizure(s) after stroke or potential risk of seizure(s);
• Switching to oral spasticity medication within 2 weeks of enrollment, or injection of botulinum toxin in the affected arm within 4 months, and/or intention to start taking spasticity medication or inject botulinum toxin during the study follow-up period or within 12 months after implantation;
• The presence of active psychosis that may affect treatment effect, such as psychosis or severe personality disorder;
• Untreated or inadequately treated depression, i.e., Beck Depression Inventory score of 20 or more at admission;
• Diagnosis of dementia;
• Uncontrolled hypertension or history of cardiovascular disease for a long time;
• MRI contraindications, such as implanted metal devices or electronic devices (pacemakers, defibrillators, spinal cord stimulators);
• Participated in another device, biological, or drug study within 30 days of consenting to participate in the current study;
• Non-pregnant or fertile women must use acceptable contraception, and pregnant women are excluded or terminated from the study;

Sponsors & Collaborators

• Beijing Municipal Administration of Hospitals: lead
• Beijing Pins Medical Co., Ltd: collaborator

Study Sites (1)

Beijing Tiantan Hospital

Beijing, 100070, China

Location

MeSH Terms

Conditions

Stroke; Paresis

Interventions

Deep Brain Stimulation; Rehabilitation

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; Surgical Procedures, Operative; Aftercare; Continuity of Patient Care; Patient Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jianguo Zhang, MD

  Department of Neurosurgery, Beijing Tiantan Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

• Zixiao Li, MD

  Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Xue, MD

CONTACT

86-18550213165; 2992326676@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, therapists, care providers, investigators, and outcomes assessors do not know which group (real DN-DBS or control) the patients are randomized. Only the programmer who programs the device settings knows which group the subject is randomized into.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of functional neurosurgery in Beijing Tiantan Hospital

Model Details: Double blind, randomized, parallel study with partial crossover (control subjects crossover to treatment after randomized portion)

Study Record Dates

• First Submitted: July 5, 2024
• First Posted: July 12, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)