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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

ConditionsRepetitive Transcranial Magnetic StimulationStrokeFunctional MRI
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-70
SponsorAssiut University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ipsilesional high frequency rTMS combined with physiotherapy

    Device

    As mentioned in details in arms description.

  • Contralesional Continuous Burst Theta rTMS (cTBS) + Physiotherapy

    Device

    As mentioned in details in arms description.

  • Sham rTMS + Physiotherapy

    Device

    As mentioned in details in arms description.

Treatment groups

90 Participants
are divided into 3 treatment groups
Group A: Ipsilesional high frequency rTMS combined with physiotherapyActive comparator 1 intervention
Group B: Contralesional Continuous Burst Theta rTMS (cTBS) + PhysiotherapyActive comparator 1 intervention
Group C: Sham rTMS + PhysiotherapySham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Score in Nottingham Sensory Assessment in points

Time frame
Within the time frame of the study , around 18 months
2

Score in modified Ashworth Scale in points

Time frame
Within the time frame of the study , around 18 months
3

Score in Fugl-Meyer assessment scale in points

Time frame
Within the time frame of the study , around 18 months

Secondary outcomes

1

Cortical Excitability Improvement

Evaluates changes in cortical excitability parameters (e.g., resting motor threshold measured in Percentage of maximum stimulator output , cortical silent period measured in milliseconds, transcallosal inhibition measured in milliseconds) using TMS after intervention.

Time frame
Within the time frame of the study , around 18 months
2

Enhancement of White Matter Integrity

Assesses changes in white matter integrity using functional MRI.

Time frame
Within the time frame of the study , around 18 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: