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

NCT07054424 | Not Yet Recruiting DMC

• 1 other identifier: 202400379A0C6001
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post-stroke Upper Limb Hemiparesis; Repetitive Transcranial Magnetic Stimulation (rTMS); Bimanual Therapy; Neuromodulation

Keywords

Stroke; neurorehabilitation; rTMS; bimanual therapy; neuromodulation; upper limb function; theta burst stimulation; brain plasticity

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assessment for Upper Extremity (FMA-UE)

  This assessment captures motor recovery across four specific domains: Part A (proximal upper limb-shoulder, elbow, and forearm), Part B (wrist), Part C (hand), and Part D (coordination and speed). The full scale ranges from 0 to 66 and the higher scores represent the better outcome.

  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 Outcomes (7)

• Modified Ashworth Scale (MAS)

  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

  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)

  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

  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)

  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.

Study Arms (3)

Control group

SHAM COMPARATOR

15 mins self-initiated stretching exercise + 50 mins conventional occupational therapy

Other: Conventional occupation therapy; Other: stretching exercise

rTMS-only group

ACTIVE COMPARATOR

15 mins rTMS and 50 mins conventional occupational therapy

Other: Conventional occupation therapy; Other: rTMS

rTMS combined with bimanual therapy group

EXPERIMENTAL

15 mins therapy (rTMS + bimanual therapy) and 50 mins conventional occupational therapy

Other: Conventional occupation therapy; Other: rTMS; Device: bimanual therapy

Interventions

Conventional occupation therapy OTHER

Standard occupational therapy focused on improving daily functional skills through task-specific training and adaptive techniques.

Control group; rTMS combined with bimanual therapy group; rTMS-only group

stretching exercise OTHER

Techniques involving passive or active stretching of muscles to enhance flexibility, reduce spasticity, and prevent contractures.

Control group

rTMS OTHER

Non-invasive brain stimulation method using magnetic pulses to modulate cortical excitability and promote neural plasticity.

rTMS combined with bimanual therapy group; rTMS-only group

bimanual therapy DEVICE

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

rTMS combined with bimanual therapy group

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Chang Gung Memorial Hospital at Linkou, Taoyuan 333, Taiwan

Taoyuan District, Taiwan

Location

Related Publications (15)

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Lyle RC. A performance test for assessment of upper limb function in physical rehabilitation treatment and research. Int J Rehabil Res. 1981;4(4):483-92. doi: 10.1097/00004356-198112000-00001. No abstract available.

  PMID: 7333761 RESULT

• De Weerdt WJG, Harrison MA. "Measuring recovery of arm-hand function in stroke patients: a comparison of the Brunnstrom-Fugl-Meyer test and the Action Research Arm test. Physiotherapy Canada. 1985; 37:65-70.

  RESULT

• Crow JL, Lincoln NB, Nouri FM, De Weerdt W. The effectiveness of EMG biofeedback in the treatment of arm function after stroke. Int Disabil Stud. 1989 Oct-Dec;11(4):155-60. doi: 10.3109/03790798909166667.

  PMID: 2701823 RESULT

• CARROLL D. A QUANTITATIVE TEST OF UPPER EXTREMITY FUNCTION. J Chronic Dis. 1965 May;18:479-91. doi: 10.1016/0021-9681(65)90030-5. No abstract available.

  PMID: 14293031 RESULT

• Mathiowetz V, Volland G, Kashman N, Weber K. Adult norms for the Box and Block Test of manual dexterity. Am J Occup Ther. 1985 Jun;39(6):386-91. doi: 10.5014/ajot.39.6.386.

  PMID: 3160243 RESULT

• Fugl-Meyer AR. Post-stroke hemiplegia assessment of physical properties. Scand J Rehabil Med Suppl. 1980;7:85-93. No abstract available.

  PMID: 6932734 RESULT

• Fugl-Meyer AR, Jaasko L, Leyman I, Olsson S, Steglind S. The post-stroke hemiplegic patient. 1. a method for evaluation of physical performance. Scand J Rehabil Med. 1975;7(1):13-31.

  PMID: 1135616 RESULT

MeSH Terms

Conditions

Stroke

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Yu-Cheng Pei, MD, PhD

CONTACT

+886 3 3281200; yspeii@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: An investigator reviewed the inclusion and exclusion criteria and assigned participants to one of the study groups. Participants were randomly allocated to either the rTMS combined with bimanual therapy group, the rTMS only group, or the control group receiving standard rehabilitation. Randomization and group assignment were performed by a research assistant using a computer-generated randomization sequence to ensure unbiased allocation. Each intervention was conducted over a 4-week period, consisting of 10 sessions, during which participants received intervention according to their assigned group.

Study Record Dates

• First Submitted: June 8, 2025
• First Posted: July 8, 2025
• Study Start: July 15, 2025
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

TW (1)