Deep Brain Stimulation of the Dentate Nucleus for Motor Rehabilitation After Stroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Municipal Administration of Hospitals
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
deep brain stimulation
DeviceStimulation of the dentate nucleus that is paired with upper limb rehabilitation movements.
Rehabilitation
Other interventionRehabilitation movements to improve upper limb function after stroke
Treatment groups
52 Participants
are divided into 2 treatment groupsGroup A: real DN-DBS + rehabilitationExperimental treatment 2 interventions
Group B: sham DN-DBS + rehabilitationActive comparator 1 intervention
Trial outcomes
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).
Time frame
V6, One day after 6-months of therapySecondary outcomes
1
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).
Time frame
V8, 90 days after 6-months of therapy2
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.
Time frame
V6, One day after 6-months of therapy3
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.
Time frame
V8, 90 days after 6-months of therapy4
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.
Time frame
V6, One day after 6-months of therapySponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing Municipal Administration of Hospitals
Lead sponsor
Beijing Tiantan Hospital
Sponsor institution
Beijing Pins Medical Co., Ltd
Collaborator
Source ClinicalTrials.gov
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