Closed - Loop Neuromodulation of Post - Stroke Motor Dysfunction by Transcranial Magnetic Stimulation Synchronized with Specific Motor Task Training
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Study Overview
Brief Summary
The goal of this clinical trials is to investigate the effectiveness of individualized online repetitive transcranial magnetic stimulation (rTMS) in enhancing upper limb motor rehabilitation during the subacute and chronic phase of stroke. It will also learn about the safety of individualized online rTMS intervention methods. The main questions it aims to answer are:
Does rTMS synchronized with motor training improve motor rehabilitation in patients with the ability to induce motor evoked potentials(MEPs)？ Dose individualized rTMS synchronized with motor training improve motor rehabilitation in patients without the ability to induce MEPs? Researchers will compare online rTMS to offline and sham stimulation in patients with MEPs to see if online rTMS works to alleviate motor dysfunction in preliminary trials. And compare individualized online rTMS to non-individualized online rTMS and sham in patients without MEPs to see if individualized online rTMS works to alleviate motor dysfunction in Randomized, double-blinded, and controlled trials.
Participants will:
randomized to one group acoording to the MEP condition of each person; receive rTMS treatment for 10 days, with 5 working days per week for a total of two weeks; receive magnetic resonance imaging (MRI) and electroencephalogram (EEG) evaluations before and after the entire treatment; conduct scales and MEP assessment one day before the treatment, as well as one day, one month, and three months after the treatment.
Detailed Description
In our experiment, patients were be randomly assigned to three groups: online, offline and sham groups. if patients were able to induce MEPs, intensity of TMS will be 80% RMT; if not , inensity of TMS will be 70% of TMS output.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •The patient is first diagnosed with stroke through neurological examination, CT or MRI scan.
- •The vital signs are stable and there is a certain degree of upper limb motor dysfunction.
- •The age is between 20 and 80 years old.
- •The cognitive ability is not significantly affected and the patient can cooperate with various examinations and assessments, with a MMSE score ≥ 20 points.
- •There are no serious complications (such as pneumonia, heart failure, urinary tract infection or malnutrition).
- •There is no pathological condition that is a contraindication for TMS in the medical history (for example, patients with metal in the brain, such as aneurysm clips, patients with a cardiac pacemaker, pregnant women, or those with a history of epileptic seizures).
- •The patient or guardian agrees to sign the informed consent form.
Exclusion Criteria
- •Patients with severe heart, lung, liver, kidney diseases and malignant tumors;
- •Those with a history of aphasia, severe cognitive impairment or mental illness;
- •Patients who have had a history of epileptic seizures in the last month or are taking anti-epileptic drugs recently;
- •Those with severe visual or hearing impairments, unable to communicate normally;
- •People with metal implants, pacemakers, skull defects or other conditions that prevent them from undergoing TMS.
Arms & Interventions
online rTMS
In the online stimulation group, the TMS treatment will continuously adjust the TMS parameters according to the baseline data and the data changes during the treatment to achieve personalized intervention. When patients receive TMS treatment, it is combined with upper limb movement tasks. When the task starts autonomously, TMS stimulation is triggered through electromyographic feedback. When the task stops or is completed, the TMS stimulation also stops immediately according to the electromyographic feedback, achieving real - time effects.
Intervention: online rTMS (Device)
offline rTMS
For the offline stimulation group, TMS treatment will be carried out before the task starts. After the stimulation ends, the subjects will then complete the task.
Intervention: offline rTMS (Device)
sham rTMS
Patients in the sham group also receive sham stimulation treatment combined with specific tasks, which is the same as the online stimulation group, except that the TMS stimulation is sham stimulation.
Intervention: sham rTMS (Device)
Outcomes
Primary Outcomes
Fugl-Meyer Assessment - Upper Extremity (FMA-UE)
Time Frame: Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 after 2-week intervention
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The Fugl-Meyer Assessment - Upper Extremity (FMA-UE) is the upper limb motor domain includes items assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, hand. It ranges from 0 (hemiplegia) to 66 points (normal motor performance).
Secondary Outcomes
- Modified Barthel Index (MBI)(Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 after 2-week intervention)
- The Pittsburgh Sleep Quality Index (PSQI)(Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 after 2-week intervention)
- Motor Evoked Potential (MEP) - Resting Motor Threshold (RMT)(Baseline; Day 1 After 2-week intervention; Day 30 after 2-week intervention; Day 60 after 2-week intervention)
- The average completion time for baseline tasks(Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day7, Day 8, Day 9, Day 10 during TMS intervention)
Investigators
Xiaonan Huang
Principal Investigator
First Affiliated Hospital of the Chinese People's Liberation Army Naval Medical University