Neuromodulation Effect of Focused Ultrasound for Motor Recovery in Patients With Stroke
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Taiwan University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
NaviFUS® Neuronavigation-guided focused ultrasound system
DeviceThe treatment protocol consists of once daily treatment for consecutive five tFUS sessions.
NaviFUS® Neuronavigation-guided focused ultrasound system
DeviceNo ultrasound energy will be delivered (Mechanical Index, MI = 0); only the background music will be played (During each treatment session, the background music will be presented in the same way as in the experimental group during the operation of the focused ultrasound system). All other stimulation settings and procedures will be identical to those used in the experimental group
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Treatment with tFUSExperimental treatment 1 intervention
Group B: ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of Treatment-related Adverse Events
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)
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.2
Cortical excitability
The amplitude and latency of maximal MEP, rMT in bilateral primary motor cortex will be assessed.
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.Secondary outcomes
1
Fugl-Meyer Assessment-Upper Extremity
The Fugl-Meyer Assessment for upper extremity is a standardized tool used to assess motor recovery after stroke. It consists of four items: shoulder/elbow/forearm, wrist, hand, and coordination. Each item is scored individually, with scores ranging from 0 to 2 depending on the quality of the movement. The total score ranges from 0 to 66, with higher scores indicating better motor function and recovery.
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.2
Medical Research Council score
The Medical Research Council (MRC) score is a simple and widely used scale to assess muscle strength. It rates muscle strength on a scale from 0 to 5, with 0 being no muscle contraction and 5 being normal muscle strength.
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.3
National Institutes of Health Stroke Scale (NIHSS)
The National Institutes of Health Stroke Scale (NIHSS) is a standardized tool used to assess the severity of a stroke and its effects on patients. It evaluates various neurological functions, such as consciousness, movement, sensation, and language, assigning scores ranging from 0 to 42, with higher scores indicating more severe stroke symptoms.
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.4
Barthel Index
The Barthel Index is a measure of a person's ability to perform activities of daily living. It assesses functions such as feeding, bathing, grooming, dressing, bowel and bladder control, toileting, transfers, mobility, and stairs. The score ranges from 0 to 100, with higher scores indicating greater independence.
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.Sponsors and contacts
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Source ClinicalTrials.gov