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StrokeNCT06498934

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

A study testing deep brain stimulation and Rehabilitation in people with Stroke and Upper Extremity Paresis, run by Beijing Municipal Administration of Hospitals at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Stroke, Upper Extremity Paresis
What is being tested?
deep brain stimulation and Rehabilitation
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
1 siteChina
Study dates
1 Sep 2024to 31 Dec 2027
Phase
Interventional
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 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
  • Exclusion of cardioembolic stroke, patients requiring long-term anticoagulation;
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  • 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;
  • Received decompressive craniectomy;
  • The patient has severe cerebral small vessel disease, basilar artery vascular disease, and/or any other structural abnormalities of the cerebellum, cerebellar peduncles, and brainstem that prevent safe placement of DBS;
  • The investigator determines that the patient has a condition that would significantly increase the risk of study non-compliance, study safety, and/or study integrity. For the safety of the subject, for example, if the subject experiences an exacerbation of their condition, a serious adverse event, or poor compliance.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tao Xue, MD contact

86-18550213165

2992326676@qq.com

China1 site

  • Beijing Tiantan Hospital

    Beijing, 100070

    Tao Xue, MD, 86-18550213165, 2992326676@qq.com

Other trials in China

About this study

Official title: Deep Brain Stimulation of Cerebellar Dentate Nucleus Promotes Upper Limb Motor Function Recovery After Ischemic Stroke: a Randomized, Double-blind, Sham-controlled 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?

Read more

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

Being tested
deep brain stimulation, Rehabilitation
Keywords
deep brain stimulation, the dentate nucleus
Medical subject headings
Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • deep brain stimulationDevice

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

  • RehabilitationOther

    Rehabilitation movements to improve upper limb function after stroke

Study groups in NCT06498934
Study groupRoleWhat they receive
real DN-DBS + rehabilitationExperimentalStudy treatment is deep brain stimulation of the dentate nucleus (DN-DBS) delivered during 6-month rehabilitation period.
Receives: Device: deep brain stimulation; Other: Rehabilitation
sham DN-DBS + rehabilitationActive comparatorActive control treatment is rehabilitation (standard-of-care treatment) with sham DN-DBS (electrode implanted but won't turn on the device).
Receives: Other: Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: V6, One day after 6-months of therapy

Secondary outcomes (5)

  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).

    Measured: V8, 90 days after 6-months of therapy

  2. 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.

    Measured: V6, One day after 6-months of therapy

  3. 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.

    Measured: V8, 90 days after 6-months of therapy

  4. 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.

    Measured: V6, One day after 6-months of therapy

  5. 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.

    Measured: V8, 90 days after 6-months of therapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2024
  2. Study start1 Sep 2024 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Double blind, randomized, parallel study with partial crossover (control subjects crossover to treatment after randomized portion)
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06498934
Sponsor's protocol ID
HX-A-2024030
Status last verified
Jul 2024
First submitted
5 Jul 2024
Last updated
18 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing deep brain stimulation and Rehabilitation in people with Stroke and Upper Extremity Paresis, run by Beijing Municipal Administration of Hospitals 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 10 inclusion and 19 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: opening soon, as of the sponsor's last update on 18 Jul 2024. 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.

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?

Contact Tao Xue, MD (86-18550213165, 2992326676@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fugl-Meyer Assessment, Upper Limb (FMA-UE) Average Change at Day 1 (time frame: V6, One day after 6-months of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06498934.

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 18 Jul 2024.

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