Clinical trial NCT05053711: Augmented Efficacy of rPMS on the rTMS on Upper Limb Function in Patients With Stroke
Official title: Augmented Efficacy of Repetitive Peripheral Magnetic Stimulation on the Repetitive Transcranial Magnetic Stimulation on Upper Limb Function in Patients With Stroke: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Keywords: Repetitive transcranial magnetic stimulation
Repetitive peripheral magnetic stimulation
stroke
novel treatment
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2021-09-22
Enrollment: 96
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Repetitive transcranial magnetic stimulation (rTMS) and repetitive peripheral magnetic stimulation (rPMS) are innovative treatments for patients with stroke. Therefore, augmented efficacy of rPMS on the rTMS is employed in this project. This proposal aims at exploring different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: augmented efficacy of rPMS on the rTMS. Several aims in this study include (1) identifying the most optimal treatment protocols for rPMS (TBS treatment and nerve stimulation location), (2 ) establish a novel treatment protocol (augmented efficacy of rPMS on the rTMS), (3) identifying augmented efficacy of rPMS on the rTMS, (4) determining the mechanism of neuro-motor control, and (5) related biomarkers for the novel treatment protocol. The investigators applied a 3-year plan before, however, the Ministry of Science and Technology plan passed one year only (108-2314-B-182-043-). The investigators carried out the pilot study to investigate the augmented effects of rPMS (radial nerve) on the rTMS in the treatment of upper limb function in patients with stroke patients. The previous plan had preliminary results. This year the investigators will apply for a three-year plan to continue the previous pilot study for getting the comprehensive results.

Detailed description: This study intends to further explore whether rPMS intervention in different nerves can augment rTMS efficacy on upper limb function in patients with stroke. A total of 72-96 patients with stroke will be recruited in 2 phases and 36-48 participants will be divided into four groups according to their severity and the onset of stroke, and then randomly enrolled into 3 groups in each phase (12-16 participants in each group) based on different rPMS- stimulated methods and location. All patients will receive the rPMS in addition rTMS on the brain cortex. In phase 1, each patient will receive either one of three rPMS methods on median nerve (iTBS, cTBS, sham). During phase 2, each patient will receive either one of three rPMS methods on ulnar nerve. Outcome measures include clinical assessments based on International Classification of Functioning, Disability and Health (ICF) and motor control (Motor Evoked Potential, MEP, kinetics, and kinematics) that administered at pretest, posttest, and 3-month follow-up. This study aims to establish a novel assessment and treatment protocols in patients with stroke. The intervention will be conducted 10 times for each participant. The optimal effective treatment protocol of augmented efficacy of rPMS on the rTMS will also be established. The results of this study will be applied to the translational and evidence-based medicine of the neuro-rehabilitation field of stroke research.

Eligibility criteria: Inclusion Criteria:

* first stoke and in stable phase
* age 20-80 years
* unilateral brain lesions with unilateral hemiplegia
* brain wave examination without epileptic waves

Exclusion Criteria:

* brain stem or cerebellar stroke
* Patients with epilepsy
* Patients with aneurysm or cerebrovascular malformation
* Patients with mental illness
* Patients with degenerative diseases (such as neurodegenerative diseases)
* Patients with severe intelligence or language barriers (such as mental retardation or severe communication impairment)
* Patients with serious medical conditions (such as heart failure)
* Patients with acute disease (such as infection)
* Patients had metal implants in the body (such as cardiac rhythm or brain metal implants, metal clips for aneurysms)
* Patients had botox injection or surgery in the first half of the study
* Pregnant woman or breastfeeding woman
* other obstacles (such as claustrophobia, obesity, etc.)

Primary outcomes:
measure: Change from baseline Motion analysis at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Motor evoked potential at afte treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Myoton at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Muscle strength at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Brunnstrom stage at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Fugl Meyer Assessment at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Modified Ashworth Scale at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
Secondary outcomes:
measure: Change from baseline Action Research Arm Test at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Box and Block Test at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Nine-Hole test at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Jebson Taylor Hand Function Test at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Functional Independence Measure at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Motor Activity Log at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Wolf Motor Function Test at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Nottingham Health Profile at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
measure: Change from baseline Stroke Impact Scale at after treatment and three month
timeFrame: baseline, after two weeks of treatment, 3 months
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memoria Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Chia-Ling Chen
role: STUDY_DIRECTOR
References: