Clinical trial NCT04265365: Efficacy of Integrated Therapy of rTMS and rPMS on Upper Limb Function in Patients With Stroke
Official title: Efficacy of Integrated Therapy of Repetitive Transcranial Magnetic Stimulation and Repetitive Peripheral Magnetic Stimulation on Upper Limb Function in Patients With Stroke
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
First posted: 2020-02-11
Enrollment: 90
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, the integrated therapy of rTMS and with repetitive peripheral magnetic stimulaiton (rPMS) is employed in this project. This proposal aims at exploring different novel treatment strategies in the treatment of UE dysfunction in patients with stroke: rTMS integrated with rPMS.

Detailed description: Several aims in this study include identifying a better protocol of rPMS with Theta burst stimulation (TBS) and different nerves stimulation location, identifying the most optimal treatment protocols for rPMS (TBS treatment and nerve stimulation location), integrating novel treatment protocol (optimal rTMS + rPMS), comparing efficacy between integrated therapy of optimal rTMS and rPMS treatment and single rTMS or rPMS treatment, determining the mechanism of neuro-motor control, clinical predictors, and related biomarkers for the novel treatment protocol A total of 108-135 patients with stroke will be recruited. During phase 1 (year 1 and year 2), 72 to 90 participants will be randomly enrolled in different groups (12-15 participants in each group). For the first year, the participants will be randomly enrolled in 3 different groups according to the TBS mode (iTBS vs.cTBS). In the second year, the participants will be randomly enrolled in 3 different groups according to the stimulated nerves (radial, median/ulnar nerves) to find the optimal novel treatment protocols for UE dysfunction in patients with stroke. During phase 2 (2-3 years), 36 to 45 patients will be randomly enrolled into 3 groups of rTMS and rPMS integrated therapy to identify optimal integrated novel treatment protocol.

Outcome measures include clinical based on International Classification of Functioning, Disability and Health (ICF) and motor control (Motor Evoked Potential, MEP; muscle tone assessment (MYOTON); pinch and grip strength and kinematics of upper extremity) assessments that administered at pretest, posttest, and 3-month follow-up. The aim of this study is to establish the novel assessment and treatment protocols in patients with stroke. The intervention will be conducted 10 times in 2 weeks (five times per week). The optimal effective treatment protocol of combination of rTMS and rPMS 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 six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Motor evoked potential at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Myoton at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Muscle strength at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Brunnstrom stage at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Fugl Meyer Assessment at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Modified Ashworth Scale at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
Secondary outcomes:
measure: Change from baseline Action Research Arm Test at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Box and Block Test at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Nine-Hole test at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Jebson Taylor Hand Function Test at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Functional Independence Measure at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Motor Activity Log at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Wolf Motor Function Test at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Nottingham Health Profile at after six weeks of treatment and three month
timeFrame: baseline, after 6 weeks of treatment, 3 months
measure: Change from baseline Stroke Impact Scale at after six weeks of treatment and three month
timeFrame: baseline, after 6 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: