Clinical trial NCT04617366: Dynamic Individualized rTMS Based on fNIRS
Official title: Effect of Dynamic Individualized rTMS Based on fNIRS on Upper Limb Function of Stroke Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Rehabilitation
Repetitive Transcranial Magnetic Stimulation
Functional Near-infrared Spectroscopy
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 50
Sex: ALL
Minimum age (years): 40
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Stroke patients do not respond well to the traditional repetitive transcranial magnetic stimulation (rTMS) strategy based on the competitive model. The studies found that the contralesional motion cortex has a compensatory effect on the realization of the motor function of the affected side-the compensatory model, and the degree of compensation will change as the function changes. The optimal neural regulation strategies under different models are opposite, so it is important to accurately evaluate which of the two models plays the leading role. And functional near-infrared spectroscopy (fNIRS) may accurately and quickly assess cortical function in order to determine the degree of participation of the contralesional motion cortex. We propose that the dynamic individualized strategy which adjust the rTMS parameters promptly based on the results of fNIRS will be better than the traditional stimulation strategy. This project will apply a blinded-assessment randomized controlled trial. The test group selects either the high-frequency rTMS to the contralesional dorsal premotor cortex (PMd) or the low-frequency rTMS to the contralesional primary motor cortex (M1) based on the lateralization index of the PMd measured by fNIRS. And the control group will always be given low-frequency rTMS to contralesional M1. The difference in the improvement of upper limb function between the two groups of patients was compared.


Eligibility criteria: Inclusion Criteria:

* Aged 40-79 years;
* Patients with first-onset subcortical infarcts within1 to 3 weeks after onset;
* TMS on the lesion side can induce motor evoked potential(MEP) of the abductor pollicis brevis muscle of the affected hand;
* Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
* The patient or its authorized agent signs the informed consent form.

Exclusion Criteria:

* Previous seizures;
* Suffered from mental illness such as depression, anxiety, mania, and schizophrenia before the stroke onset;
* Patients with metal on the head, cochlear implants, intracranial infections, etc. who are not suitable for rTMS.

Primary outcomes:
measure: Fugl-Meyer motor function score of upper limb
timeFrame: 3 months
Secondary outcomes:
measure: Barthel index
timeFrame: 3 months
measure: Lateralization index (LI)
timeFrame: 3 months
measure: Brain functional connection network
timeFrame: 3 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
References: