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This clinical trial will evaluate if Deep Brain Stimulation (DBS) is safe for the treatment of stroke and will help understand if DBS improves motor recovery for patients who continue to have significant impairment.
The proposed study is a safety and feasibility study intended to provide preliminary data to design a future pilot study. The objective of this study is to document the safety and patient outcomes of electrical stimulation of the dentate nucleus area for the management of chronic, moderate to severe upper extremity hemiparesis due to ischemic stroke.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electrical Stimulation | Experimental | This is a single arm study and all subjects will receive electrical stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep Brain Stimulation | Device | Electrical stimulation of the dentate nucleus area of the cerebellum. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | Incidence of study-related serious adverse events | 18 Months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andre Machado, MD, PhD | The Cleveland Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38156644 | Derived | Li X, Baker KB, O'Laughlin K, Chen J, Hogue O, Machado AG, Plow EB. Paired DBS and TMS Reveals Dentato-Cortical Facilitation Underlying Upper Extremity Movement in Chronic Stroke Survivors. Neurorehabil Neural Repair. 2024 Feb;38(2):109-121. doi: 10.1177/15459683231219265. Epub 2023 Dec 29. | |
| 37580534 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | DBS+Rehab | This was a single-arm study, and all subjects received Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus rehab (DBS+Rehab) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DBS+Rehab | This was a single-arm study, and all subjects received Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus rehab (DBS+Rehab) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adverse Events | Incidence of study-related serious adverse events | Posted | Number | study-related, serious adverse events | 18 Months |
|
|
18 Months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DBS+Rehab | This was a single-arm study, and all subjects received Deep Brain Stimulation (DBS) of the dentate nucleus area of the cerebellum plus rehab (DBS+Rehab) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low potassium / hypokalemia (Non Study-Related) | Blood and lymphatic system disorders | Non-systematic Assessment | The subject went to a nearby Emergency Department for nausea and vomiting and was admitted for Hypokalemia; per definition, hospitalization is reported as an SAE. The subject had a history of Hypokalemia. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post-anesthesia nausea | Surgical and medical procedures | Systematic Assessment | See published article for details of all AEs: Baker KB, et al. Cerebellar deep brain stimulation for chronic post-stroke motor rehabilitation: a phase I trial. Nature Medicine. 2023;10.1038. https://doi.org/10.1038/s41591-023-02507-0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Trials | Enspire DBS Therapy, Inc. | 123-456-7890 | info@enspiredbs.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 29, 2020 | Sep 8, 2023 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D000083242 | Ischemic Stroke |
| 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 |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
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| Baker KB, Plow EB, Nagel S, Rosenfeldt AB, Gopalakrishnan R, Clark C, Wyant A, Schroedel M, Ozinga J 4th, Davidson S, Hogue O, Floden D, Chen J, Ford PJ, Sankary L, Huang X, Cunningham DA, DiFilippo FP, Hu B, Jones SE, Bethoux F, Wolf SL, Chae J, Machado AG. Cerebellar deep brain stimulation for chronic post-stroke motor rehabilitation: a phase I trial. Nat Med. 2023 Sep;29(9):2366-2374. doi: 10.1038/s41591-023-02507-0. Epub 2023 Aug 14. |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
| 0 |
| 12 |
| 1 |
| 12 |
| 9 |
| 12 |
|
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| Post-surgical incision pain/sensitivity or headache | Surgical and medical procedures | Systematic Assessment |
|
| IPG site pain/redness | Surgical and medical procedures | Systematic Assessment |
|
| Nausea and vomiting during DBS programming | Surgical and medical procedures | Systematic Assessment |
|
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |