Repetitive Transcranial Magnetic Stimulation Combined With Bimanual Therapy for Upper Limb Stroke Rehabilitation

Official title

Development of Repetitive Transcranial Magnetic Stimulation (rTMS) Combined With Machine-assisted Bimanual Therapy (BT) in Upper Limb Rehabilitation

Overview

The goal of this clinical trial is to evaluate whether combining repetitive transcranial magnetic stimulation (rTMS) with machine-assisted bimanual therapy (BT) can improve upper limb function in stroke patients. The participants will be individuals aged 40-80 years who have experienced a first-time ischemic or hemorrhagic stroke. The main questions it aims to answer are: * Does the combined therapy enhance motor recovery compared to traditional rehabilitation methods? * Are changes in brain activity associated with improvements in upper limb function? Participants will be randomly assigned to different groups and will: * Receive rTMS stimulation on specific areas of the brain to modulate neural activity, * Perform machine-assisted bimanual exercises to promote motor skills, and * Undergo assessments before, immediately after, and during follow-up periods to measure functional improvements.

Interventions

• Other Conventional occupation therapy
  Standard occupational therapy focused on improving daily functional skills through task-specific training and adaptive techniques.
• Other stretching exercise
  Techniques involving passive or active stretching of muscles to enhance flexibility, reduce spasticity, and prevent contractures.
• Other rTMS
  Non-invasive brain stimulation method using magnetic pulses to modulate cortical excitability and promote neural plasticity.
• Device bimanual therapy
  A training approach that involves simultaneous use of both hands to enhance coordination and functional hand movements through guided exercises, including device-assisted and robot-assisted therapy

Primary outcome measures

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE) [Time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.]

Secondary outcome measures (7)

• Modified Ashworth Scale (MAS) [Time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.]
• Upper Extremities Muscle Strength [Time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.]
• Action Reach Arm Test (ARAT) [Time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.]
• Brunnstrom Recovery Stage [Time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.]
• Instrumental Activities of Daily Living Scale (IADLs) [Time frame: Evaluated at before and after (immediately following the final sessions) the intervention. Additionally, follow-up assessments are conducted at 1 month and 3 months post-treatment to evaluate sustained effects.]
• System Usability Scale (SUS) [Time frame: Administered once immediately after the final intervention session to capture the participant's impressions of the device's usability.]
• Satisfaction Questionnaire [Time frame: Administered once immediately after the final intervention session to assess participants' subjective satisfaction with the intervention.]

Eligibility criteria

Inclusion criteria

• Age 40-80 years;
• First-onset stroke patients;
• Patients diagnosed with cerebral infarction or hemorrhage through CT or MRI;
• Signed informed consent form by the patient and their family;
• Stable physiological parameters;
• Stroke occurred within the last 12 months;
• Patients with unilateral hand function impairment caused by the stroke;
• Upper limb muscle tone (Modified Ashworth Scale, MAS) less than 3 points;
• Able to follow two-step commands.

Exclusion criteria

• A history of epilepsy or family history of epilepsy;
• Presence of suicidal tendencies;
• Currently using medications that lower the seizure threshold;
• Pregnant or planning to become pregnant;
• Co-existing neurological diseases (such as multiple sclerosis, other neurodegenerative diseases, meningitis, brain abscess, or meningioma);
• Subjects with uncontrollable migraines caused by elevated intracranial pressure;
• Subjects taking antidepressants who cannot discontinue the medication;
• Subjects with sleep disorders during rTMS treatment;
• Subjects with cerebellar stroke or brainstem stroke;
• Cerebral ischemic disorders resulting from traumatic brain injury;
• Transient ischemic attacks (TIAs);
• History of bleeding tendency and other conditions affecting upper limb function, such as myasthenia gravis, systemic immune neuropathy, severe epilepsy, endocrine system disorders, wearers of external or internal cardiac pacemakers, individuals with metallic implants or orthopedic devices;
• Co-existing severe heart, liver, kidney dysfunction, or other serious physical illnesses;
• Subjects with impaired consciousness who cannot cooperate with examinations or treatments, such as those with mental disorders, or those with intellectual or cognitive impairments, severe dementia;
• Presence of implanted electronic devices in the body;
• Co-existing severe liver, kidney, or hematological disorders;
• Special vulnerable populations;
• Skin disease (e.g., pressure ulcers, trauma, cellulitis, etc.).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Linkou — Taoyuan

Publications

• Kim WS, Paik NJ. Safety Review for Clinical Application of Repetitive Transcranial Magnetic Stimulation. Brain Neurorehabil. 2021 Mar 18;14(1):e6. doi: 10.12786/bn.2021.14.e6. eCollection 2021 Mar. PMID 36742107
• Oberman L, Edwards D, Eldaief M, Pascual-Leone A. Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. J Clin Neurophysiol. 2011 Feb;28(1):67-74. doi: 10.1097/WNP.0b013e318205135f. PMID 21221011
• Liu C, Li L, Li B, Liu Z, Xing W, Zhu K, Jin W, Lin S, Tan W, Ren L, Zhang Q. Efficacy and Safety of Theta Burst Versus Repetitive Transcranial Magnetic Stimulation for the Treatment of Depression: A Meta-Analysis of Randomized Controlled Trials. Neuromodulation. 2024 Jun;27(4):701-710. doi: 10.1016/j.neurom.2023.08.009. Epub 2023 Oct 12. PMID 37831019
• Huang YZ, Edwards MJ, Rounis E, Bhatia KP, Rothwell JC. Theta burst stimulation of the human motor cortex. Neuron. 2005 Jan 20;45(2):201-6. doi: 10.1016/j.neuron.2004.12.033. PMID 15664172
• Li X, Lin YL, Cunningham DA, Wolf SL, Sakaie K, Conforto AB, Machado AG, Mohan A, O'Laughlin K, Wang X, Widina M, Plow EB. Repetitive Transcranial Magnetic Stimulation of the Contralesional Dorsal Premotor Cortex for Upper Extremity Motor Improvement in Severe Stroke: Study Protocol for a Pilot Randomized Clinical Trial. Cerebrovasc Dis. 2022;51(5):557-564. doi: 10.1159/000521514. Epub 2022 Jan 20 PMID 35051941
• Chen YM, Lai SS, Pei YC, Hsieh CJ, Chang WH. Development of a Novel Task-oriented Rehabilitation Program using a Bimanual Exoskeleton Robotic Hand. J Vis Exp. 2020 May 20;(159). doi: 10.3791/61057. PMID 32510515
• Huang JJ, Pei YC, Chen YY, Tseng SS, Hung JW. Bilateral Sensorimotor Cortical Communication Modulated by Multiple Hand Training in Stroke Participants: A Single Training Session Pilot Study. Bioengineering (Basel). 2022 Nov 24;9(12):727. doi: 10.3390/bioengineering9120727. PMID 36550934
• Chen JL, Ros T, Gruzelier JH. Dynamic changes of ICA-derived EEG functional connectivity in the resting state. Hum Brain Mapp. 2013 Apr;34(4):852-68. doi: 10.1002/hbm.21475. Epub 2012 Feb 17. PMID 22344782

Identifiers

NCT: NCT07054424 · 202400379A0C6001

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗