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| Name | Class |
|---|---|
| Beijing Pins Medical Co., Ltd | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| real DN-DBS + rehabilitation | Experimental | Study treatment is deep brain stimulation of the dentate nucleus (DN-DBS) delivered during 6-month rehabilitation period. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| deep brain stimulation | Device | Stimulation of the dentate nucleus that is paired with upper limb rehabilitation movements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change at Day 90 | The Fugl-Meyer Assessment, Upper Limb (FMA-UE) was analyzed for difference in average change at Day-90 after 6-months of therapy compared to baseline (Difference in average change in FMA-UE from baseline [V0] to 90 days after therapy [V8]). 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Xue, MD | Contact | 86-18550213165 | 2992326676@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital | Beijing | 100070 | China |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D010291 | Paresis |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D046690 | Deep Brain Stimulation |
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D000359 | Aftercare |
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Double blind, randomized, parallel study with partial crossover (control subjects crossover to treatment after randomized portion)
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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.
| Rehabilitation | Other | Rehabilitation movements to improve upper limb function after stroke |
|
| V8, 90 days after 6-months of therapy |
| Wolf Motor Function Test (WMFT) Average Change at Day 1 | The Wolf Motor Function Test (WMFT) is an assessment scale of upper extremity functional level after stroke. The functional assessment range is an average of 15 sub-items with a range from 0 to 5, with 0 (meaning did not attempt) to 5 (meaning normal). WMFT Day 1 - is a measure of the functional assessment change from baseline to one day after 6-months of therapy. | V6, One day after 6-months of therapy |
| Wolf Motor Function Test (WMFT) Average Change at Day 90 | The Wolf Motor Function Test (WMFT) is an assessment scale of upper extremity functional level after stroke. The functional assessment range is an average of 15 sub-items with a range from 0 to 5, with 0 (meaning did not attempt) to 5 (meaning normal). WMFT Day 90 - is a measure of the functional assessment change from baseline to 90 days after 6-months of therapy. | V8, 90 days after 6-months of therapy |
| Action Research Arm Test (ARAT) Average Change at Day 1 | Action Research Arm Test (ARAT) is a common scale of fine movements of distal upper limbs after stroke. The functional assessment range is an average of 19 sub-items with a range from 0 to 3, with 0 (meaning did not attempt) to 5 (meaning normal). ARAT Day 1 - is a measure of the functional assessment change from baseline to one day after 6-months of therapy. | V6, One day after 6-months of therapy |
| Action Research Arm Test (ARAT) Average Change at Day 90 | Action Research Arm Test (ARAT) is a common scale of fine movements of distal upper limbs after stroke. The functional assessment range is an average of 19 sub-items with a range from 0 to 3, with 0 (meaning did not attempt) to 5 (meaning normal). ARAT Day 90 - is a measure of the functional assessment change from baseline to 90 days after 6-months of therapy. | V8, 90 days after 6-months of therapy |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003266 |
| Continuity of Patient Care |
| D005791 | Patient Care |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |