Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke
Overview
- Phase
- Not Applicable
- Intervention
- NaviFUS® Neuronavigation-guided focused ultrasound system
- Conditions
- Focused Ultrasound
- Sponsor
- National Taiwan University Hospital
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-related Adverse Events
- Status
- Recruiting
- Last Updated
- 19 days ago
Overview
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 to the primary motor cortex on the healthy side. The treatment protocol consists of once daily treatment for consecutive five tFUS sessions. 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. The evaluation will be conducted before treatment and on the first day, first week, fourth week, and twelfth week after completing tFUS. The second part of this study is an efficacy investigation, which plans to recruit 30 subacute stroke patients for a randomized controlled trial with a parallel-group design. The experimental group will receive focused ultrasound stimulation with the same parameters and target site as the Phase I pilot study, while the control group will receive sham stimulation at the same location. The treatment frequency will be the same as that of the pilot study.
Investigators
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;
Arms & Interventions
Treatment with tFUS
Treatment with tFUS
Intervention: NaviFUS® Neuronavigation-guided focused ultrasound system
Control
No ultrasound energy, only the background music will be played.
Intervention: NaviFUS® Neuronavigation-guided focused ultrasound system
Outcomes
Primary Outcomes
Incidence of Treatment-related Adverse Events
Time Frame: 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.
Includes rate of minor (scalp pain, headache, short-term dizziness, nausea, vomiting, short-term weakness, short-term numbness) and severe adverse events (seizure, persistent new onset weakness, documented new intracranial hemorrhage or infarction, death)
Cortical excitability
Time Frame: 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.
The amplitude and latency of maximal MEP, rMT in bilateral primary motor cortex will be assessed.
Secondary Outcomes
- Wolf Motor Function Test(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.)
- Stroke Impact Scale(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.)
- Fugl-Meyer Assessment-Upper Extremity(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.)
- Medical Research Council score(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.)
- National Institutes of Health Stroke Scale (NIHSS)(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.)
- Functional brain activities(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.)
- Barthel Index(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.)
- Modified Rankin Scale(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.)