Repetitive Transcranial Magnetic StimulationNCT06799312
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
A study testing Ipsilesional high frequency rTMS combined with physiotherapy and Contralesional Continuous Burst Theta rTMS (cTBS) + Physiotherapy in people with Repetitive Transcranial Magnetic Stimulation and Stroke, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Repetitive Transcranial Magnetic Stimulation, Stroke, Functional MRI
- What is being tested?
- Ipsilesional high frequency rTMS combined with physiotherapy and Contralesional Continuous Burst Theta rTMS (cTBS) + Physiotherapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 15 Mar 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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: A Double-blinded Randomized Clinical 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.
Read the detailed description
Globally, stroke is the second leading cause of both death and disability. In 2020, the global prevalence of all stroke subtypes was 89.13 million cases, with acute ischemic stroke (AIS) comprising 76.47% of these, equating to 68.16 million cases . AIS presents a major global public health concern, given the wide range of disabilities it causes, including cognitive impairments. Survivors of stroke bear a significant burden due to the persistent disability they experience over time . Immediately following a stroke, motor impairments are accompanied by significant alterations in the affected primary motor cortex (M1) - detected by transcranial magnetic stimulation (TMS)- resulting in reduced cortical excitability. This can be evidenced by the absence of recordable motor evoked potentials (MEPs), diminished MEP amplitudes, and increased resting motor threshold (rMT). Additionally, stroke can alter brain connectivity, particularly in terms of functional connectivity, which has implications for recovery. Neuroplasticity plays a crucial role in recovery after stroke, allowing the brain to reorganize and compensate for lost functions. Physiotherapy is a cornerstone of post-stroke rehabilitation, particularly for upper limb recovery and cognitive improvement, with early intervention associated with better outcomes. Repetitive transcranial magnetic stimulation (rTMS) has shown promise in the early stages post-stroke, enhancing motor and cognitive recovery, particularly when applied within two weeks of stroke onset. MEPs can be used to monitor changes in cortical excitability and have been linked to both cognitive and motor recovery. Combining rTMS with diffusion tensor imaging (DTI) allows for the assessment of both functional and structural brain changes, providing a deeper understanding of rTMS's therapeutic effects. DTI, through fractional anisotropy (FA), helps to evaluate white matter integrity, and studies have shown that increased FA correlates with motor recovery, making it a valuable tool in examining the structural changes induced by rTMS in stroke recovery. While high frequency rTMS targeting the ipsilesional motor cortex (M1) has demonstrated efficacy in enhancing motor recovery, contralesional continuous theta-burst stimulation (cTBS) has shown promising results offering an alternative by modulating interhemispheric inhibition. However, no studies have directly compared the efficacy of these two paradigms against each other and sham stimulation in subacute stroke recovery. This study seeks to address this gap by comparing the outcomes of lesional high frequency rTMS, contralesional cTBS, and sham stimulation in combination with physiotherapy.
- Being tested
- Ipsilesional high frequency rTMS combined with physiotherapy, Contralesional Continuous Burst Theta rTMS (cTBS) + Physiotherapy, Sham rTMS + Physiotherapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ipsilesional high frequency rTMS combined with physiotherapyDevice
As mentioned in details in arms description.
Contralesional Continuous Burst Theta rTMS (cTBS) + PhysiotherapyDevice
As mentioned in details in arms description.
Sham rTMS + PhysiotherapyDevice
As mentioned in details in arms description.
| Study group | Role | What they receive |
|---|---|---|
| Ipsilesional high frequency rTMS combined with physiotherapy | Active comparator | rTMS 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. Receives: Device: Ipsilesional high frequency rTMS combined with physiotherapy |
| Contralesional Continuous Burst Theta rTMS (cTBS) + Physiotherapy | Active comparator | rTMS 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. Receives: Device: Contralesional Continuous Burst Theta rTMS (cTBS) + Physiotherapy |
| Sham rTMS + Physiotherapy | Sham comparator | Patients 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. Receives: Device: Sham rTMS + Physiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score in Nottingham Sensory Assessment in points
Measured: Within the time frame of the study , around 18 months
Score in modified Ashworth Scale in points
Measured: Within the time frame of the study , around 18 months
Score in Fugl-Meyer assessment scale in points
Measured: Within the time frame of the study , around 18 months
Secondary outcomes (2)
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.
Measured: Within the time frame of the study , around 18 months
Enhancement of White Matter Integrity
Assesses changes in white matter integrity using functional MRI.
Measured: Within the time frame of the study , around 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start15 Mar 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Repetitive Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A double blinded randomized controlled trial comparing different interventions on separate groups simultaneously.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Ahmad Mohammad Korayem, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799312
- Sponsor's protocol ID
- NeuroRehabStroke2025
- Status last verified
- Mar 2025
- First submitted
- 15 Jan 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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: A Double-blinded Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06799312
- Acronym / sponsor ID
- NeuroRehabStroke2025
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Mar 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Globally, stroke is the second leading cause of both death and disability. In 2020, the global prevalence of all stroke subtypes was 89.13 million cases, with acute ischemic stroke (AIS) comprising 76.47% of these, equating to 68.16 million cases . AIS presents a major global public health concern, given the wide range of disabilities it causes, including cognitive impairments. Survivors of stroke bear a significant burden due to the persistent disability they experience over time . Immediately following a stroke, motor impairments are accompanied by significant alterations in the affected primary motor cortex (M1) - detected by transcranial magnetic stimulation (TMS)- resulting in reduced cortical excitability. This can be evidenced by the absence of recordable motor evoked potentials (MEPs), diminished MEP amplitudes, and increased resting motor threshold (rMT). Additionally, stroke can alter brain connectivity, particularly in terms of functional connectivity, which has implications for recovery. Neuroplasticity plays a crucial role in recovery after stroke, allowing the brain to reorganize and compensate for lost functions. Physiotherapy is a cornerstone of post-stroke rehabilitation, particularly for upper limb recovery and cognitive improvement, with early intervention associated with better outcomes. Repetitive transcranial magnetic stimulation (rTMS) has shown promise in the early stages post-stroke, enhancing motor and cognitive recovery, particularly when applied within two weeks of stroke onset. MEPs can be used to monitor changes in cortical excitability and have been linked to both cognitive and motor recovery. Combining rTMS with diffusion tensor imaging (DTI) allows for the assessment of both functional and structural brain changes, providing a deeper understanding of rTMS's therapeutic effects. DTI, through fractional anisotropy (FA), helps to evaluate white matter integrity, and studies have shown that increased FA correlates with motor recovery, making it a valuable tool in examining the structural changes induced by rTMS in stroke recovery. While high frequency rTMS targeting the ipsilesional motor cortex (M1) has demonstrated efficacy in enhancing motor recovery, contralesional continuous theta-burst stimulation (cTBS) has shown promising results offering an alternative by modulating interhemispheric inhibition. However, no studies have directly compared the efficacy of these two paradigms against each other and sham stimulation in subacute stroke recovery. This study seeks to address this gap by comparing the outcomes of lesional high frequency rTMS, contralesional cTBS, and sham stimulation in combination with physiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- A double blinded randomized controlled trial comparing different interventions on separate groups simultaneously.
| Arm | Type | Receives |
|---|---|---|
| Ipsilesional high frequency rTMS combined with physiotherapy | Active comparator | Device: Ipsilesional high frequency rTMS combined with physiotherapyrTMS 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 comparator | Device: Contralesional Continuous Burst Theta rTMS (cTBS) + PhysiotherapyrTMS 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 comparator | Device: Sham rTMS + PhysiotherapyPatients 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ipsilesional high frequency rTMS combined with physiotherapyAs mentioned in details in arms description. | Device | Ipsilesional high frequency rTMS combined with physiotherapy |
| Contralesional Continuous Burst Theta rTMS (cTBS) + PhysiotherapyAs mentioned in details in arms description. | Device | Contralesional Continuous Burst Theta rTMS (cTBS) + Physiotherapy |
| Sham rTMS + PhysiotherapyAs mentioned in details in arms description. | Device | Sham rTMS + Physiotherapy |
Primary outcome
Score in Nottingham Sensory Assessment in points
Time frame: Within the time frame of the study , around 18 months
Score in modified Ashworth Scale in points
Time frame: Within the time frame of the study , around 18 months
Score in Fugl-Meyer assessment scale in points
Time frame: Within the time frame of the study , around 18 months
2 secondary outcomes
Cortical Excitability Improvement
Time frame: Within the time frame of the study , around 18 months
Enhancement of White Matter Integrity
Time frame: Within the time frame of the study , around 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Ipsilesional high frequency rTMS combined with physiotherapy and Contralesional Continuous Burst Theta rTMS (cTBS) + Physiotherapy in people with Repetitive Transcranial Magnetic Stimulation and Stroke, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad Ahmad Korayem, Assistant lecturer (+201021478054, Mohammadkorayem@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score in Nottingham Sensory Assessment in points (time frame: Within the time frame of the study , around 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2025.