Clinical trial NCT06391086: Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke
Official title: Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Focused Ultrasound
Stroke
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-04-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Transcranial focused ultrasound (tFUS) can be used as a non-invasive brain neuromodulation technique. Low-intensity focused ultrasound has been demonstrated to be safe and have neuromodulatory effects on the cerebral cortex in healthy human and animal experiments.This study aims to investigate the effect of tFUS on cortical excitability for motor recovery in patients with stroke.

Detailed description: The study is a pilot study for feasibility, which aims to recruit 20 patients with subacute (within 3 months) stroke and unilateral hemiparesis. tFUS stimulation will be delivered. The primary outcomes are defined as cortical excitability assessment in bilateral primary motor cortex, as well as safety analysis; the secondary outcome measures include the Fugl-Meyer Assessment, Medical Research Council score, National Institutes of Health Stroke Scale (NIHSS), Barthel Index, Modified Rankin Scale and functional brain activities.

Eligibility criteria: Inclusion Criteria:

* Patients with stroke (including hemorrhagic or ischemic stroke) diagnosed by a board-certificated physician.
* Occurrence of stroke within three months.
* Upper limb muscle strength ≤ 4 points according to the Medical Research Council Manual Muscle Testing scale.
* No previous history of stroke, epilepsy, dementia, Parkinson's disease, or other neurodegenerative diseases.
* Patients could maintain sitting posture for more than 15 minutes on a chair.
* 18 years of age or older.

Exclusion Criteria:

* History of recurrent stroke, traumatic brain injuries, brain tumors, spinal cord injury, Parkinson's disease or other musculoskeletal system diseases that may affect evaluation and treatment.
* Contraindications to focused ultrasound, including pregnancy, cardiac pacemaker or implantable medical device, abnormal connective tissue diseases, coagulopathy (PLT\<100,000/μL, PT\>14 seconds, APTT\>36 seconds, INR\>1.3), implants near or in the brain, or those deemed Unsuitable for this treatment by the physician.
* Unable to cooperate with treatment or functional assessment due to impaired consciousness or aphasia; inability to informed consent.
* Patient with cranial bone factor causing the inability of tFUS penetration.
* Patient under anticoagulants with coagulopathy (PLT\<100,000/μL, PT\>14 seconds, APTT\>36 seconds, INR\>1.3)
* Patients who are not suitable for undergoing CT imaging examination;
* Major physical illnesses and neurological disorders (such as epilepsy, brain surgery, etc.)
* Patients with metallic implants in their bodies;
* Patients taking tricyclic antidepressants, analgesics, or using antiepileptic drugs
* Individuals experiencing sleep disorders during tFUS treatment;
* Individuals with history of alcoholism
* Patients with severe or uncontrollable intracranial pressure;
* Patients requiring anticoagulants;
* Any intracranial space-occupying lesions;
* Significant calcification of intracranial vessels based on pre-treatment CT imaging;
* Subjects with lesions/wounds on the scalp in the target region.

Primary outcomes:
measure: Incidence of Treatment-related Adverse Events
timeFrame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
measure: Cortical excitability
timeFrame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Secondary outcomes:
measure: Fugl-Meyer Assessment-Upper Extremity
timeFrame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
measure: Medical Research Council score
timeFrame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
measure: Barthel Index
timeFrame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
measure: Modified Rankin Scale
timeFrame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
measure: Functional brain activities
timeFrame: Before treatment and on the first day (equal to day 6), first week (equal to day 12), fourth week (equal to day 33), and twelfth week (equal to day 89) after completing consecutive five tFUS sessions.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Meng Ting Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: