Comparative Effectiveness of Ipsilesional High-frequency rTMS, Contralesional Continuous Burst Theta rTMS, and Sham rTMS, Each Combined With Physiotherapy, in Subacute Ischemic Stroke Upper Limb Recovery : Clinical, Neurophysiological and Radiological
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
To compare the efficacy of lesional high-frequency rTMS, contralesional cTBS, and sham stimulation in improving motor and cognitive recovery in post-stroke patients undergoing physiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2025
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2025
CompletedFirst Posted
Study publicly available on registry
January 29, 2025
CompletedStudy Start
First participant enrolled
March 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 5, 2025
March 1, 2025
1.5 years
January 15, 2025
March 2, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
Score in Nottingham Sensory Assessment in points
Within the time frame of the study , around 18 months
Score in modified Ashworth Scale in points
Within the time frame of the study , around 18 months
Score in Fugl-Meyer assessment scale in points
Within the time frame of the study , around 18 months
Secondary Outcomes (2)
Cortical Excitability Improvement
Within the time frame of the study , around 18 months
Enhancement of White Matter Integrity
Within the time frame of the study , around 18 months
Study Arms (3)
Ipsilesional high frequency rTMS combined with physiotherapy
ACTIVE COMPARATORrTMS Protocol: Stimulation delivered to the hand area of the ipsilesional primary motor cortex (M1). Frequency: 3 Hz. Stimulation: 2 seconds per train, 37 trains per session. Total pulses: 750 per session at 130% of the resting motor threshold (RMT). Physiotherapy: Patients receive standard physiotherapy sessions.
Contralesional Continuous Burst Theta rTMS (cTBS) + Physiotherapy
ACTIVE COMPARATORrTMS Protocol: Stimulation delivered to the contralesional primary motor cortex (M1). Protocol: Continuous bursts of 3 stimuli at 50 Hz, repeated at 5 bursts per second. Duration: 40 seconds per session. Stimulation intensity: 70% of RMT with a biphasic TMS-induced current at a 45° angle to the midline. Physiotherapy: Patients receive standard physiotherapy sessions.
Sham rTMS + Physiotherapy
SHAM COMPARATORPatients receive a sham stimulation designed to mimic rTMS without delivering active magnetic pulses. This maintains blinding for participants and investigators. Physiotherapy: Patients receive standard physiotherapy sessions.
Interventions
As mentioned in details in arms description.
As mentioned in details in arms description.
As mentioned in details in arms description.
Eligibility Criteria
You may qualify if:
- First-ever ischemic stroke, confirmed by imaging.
- Stroke affecting the non-dominant hemisphere (cortical or subcortical) within the middle cerebral artery (MCA) territory.
- Acute to subacute stage of stroke (time since onset: 48 hours to 2 weeks).
- Ability to comply with the study protocol and interventions.
You may not qualify if:
- Hemorrhagic stroke or bilateral stroke.
- Severe cognitive impairment, defined as a Montreal Cognitive Assessment (MoCA) score \< 10.
- Contraindications to TMS, such as: History of epilepsy, Metallic implants in the head, Other contraindications based on TMS safety guidelines.
- Comorbid conditions that limit participation in rehabilitation.
- Severe neglect or aphasia that would impede participation in therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Both participants and investigators are blinded to the intervention type, with sham rTMS serving as the control for maintaining blinding integrity.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assisstant lecturer
Study Record Dates
First Submitted
January 15, 2025
First Posted
January 29, 2025
Study Start
March 15, 2025
Primary Completion (Estimated)
September 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 5, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share