Augmented Efficacy of rPMS on the rTMS on Upper Limb Function in Patients With Stroke

Chang Gung Medical Foundation

Status: Enrolling

Conditions: Stroke

Treatments: Device: rTMS+rPMS_cTBS_M; Device: rTMS+sham rPMS_U; Device: rTMS+rPMS_iTBS_M; Device: rTMS+rPMS_iTBS_U; Device: rTMS+rPMS_cTBS_U; Device: rTMS+sham rPMS_M

Study type: Interventional

Funder types: Other

Identifiers

NCT05053711

202002582A3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 96 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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96 participants in 6 patient groups

rTMS+rPMS_iTBS_M

Experimental group

Description:

In this group, they received iTBS on affected hemisphere after following iTBS at median nerve on affected hand.

Treatment:

Device: rTMS+rPMS_iTBS_M

rTMS+rPMS_cTBS_M

Experimental group

Description:

In this group, they received iTBS on affected hemisphere after following cTBS at median nerve on affected hand.

Treatment:

Device: rTMS+rPMS_cTBS_M

rTMS+sham rPMS_M

Sham Comparator group

Description:

In this group, they received iTBS on affected hemisphere after following sham TBS stimulation at median nerve on affected hand.

Treatment:

Device: rTMS+sham rPMS_M

rTMS+rPMS_iTBS_U

Experimental group

Description:

In this group, they received iTBS on affected hemisphere after following iTBS at ulnar nerve on affected hand.

Treatment:

Device: rTMS+rPMS_iTBS_U

rTMS+rPMS_cTBS_U

Experimental group

Description:

In this group, they received iTBS on affected hemisphere after following cTBS at ulnar nerve on affected hand.

Treatment:

Device: rTMS+rPMS_cTBS_U

rTMS+sham rPMS_U

Sham Comparator group

Description:

In this group, they received iTBS on affected hemisphere after following sham TBS stimulation at ulnar nerve on affected hand.

Treatment:

Device: rTMS+sham rPMS_U