Post Stroke AphasiaNCT04708197
Effect of High Frequency Transcranial Magnetic Stimulation on Recovery of Chronic Post-Stroke Aphasia
A study testing rTMS (repetitive transcranial magnetic stimulation ) in people with Post Stroke Aphasia, run by Cairo University at 1 site in Egypt.
Trial summary
high frequency excitatory rTMS applied over the dominant hemisphere in chronic post stroke aphasic patients to help the restoration of function by the left hemisphere Read more about this study
- Who is it for?
- Ages 33 to 66 years
- Conditions the study is for
- Post Stroke Aphasia
- What is being tested?
- rTMS (repetitive transcranial magnetic stimulation )
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 33 to 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- chronic post stroke nonfluent aphasia due to first-ever ischemic stroke in the distribution of middle cerebral artery diagnosed clinically and documented by computed tomography or magnetic resonance imaging on the brain
- Right handedness
- Both sexe groups
- Age ranged from 33 to 66 years old,
- Duration is at least 4 months from stroke onset,
- patients never received speech therapy before
- Educated for at least 10 years of education.
Who cannot join
- Aphasia due to head injury or neurological disease other than stroke,
- unstable cardiac dysrhythmia or cardiac pacemaker
- unstable or critically ill patients
- current or history of epilepsy, skull wounds and pregnant females.
- patients with severe grade of weakness which interfere with writing ability.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of rTMS in Recovery of Chronic Post Stroke Aphasia
high frequency excitatory rTMS applied over the dominant hemisphere in chronic post stroke aphasic patients to help the restoration of function by the left hemisphere
Read the detailed description
Repetitive transcranial magnetic stimulation (rTMS) has been used in many studies as a novel intervention to treat disorders associated with stroke, including paralysis or dysphagia, hemispatial neglect, pain, and aphasia. Number of studies have demonstrated that low-frequency rTMS over the unaffected hemisphere can be useful for enhancing recovery in aphasic patients.. It is expected that application of high-frequency (facilitatory) rTMS over the dominant speech area would have a beneficial effect on improving speech performance.
The aim of this study is to evaluate the effect of excitatory high frequency rTMS on recovery of aphasia in chronic aphasic patients due to cerebrovascular stroke. Twenty patients with post-stroke aphasia were enrolled in this study. Patients were selected from those attending the stroke clinic of Neurology department, Cairo University during the period from June 2020 to November 2020. The protocol of the study was approved by the ethical committee of the Department of Neurology, Faculty of Medicine, Cairo University. The aim and procedures of the study were explained and written consent forms were taken from all patients prior to participation.
The eligibility criteria were: chronic post stroke nonfluent aphasia due to first-ever ischemic stroke in the distribution of middle cerebral artery diagnosed clinically and documented by computed tomography or magnetic resonance imaging on the brain, right handedness, both sexes, age ranged from 33 to 66 years old, duration at least 4 months from stroke onset, patients not receiving speech therapy and educated at least 10 years of education.
Exclusion criteria were: aphasia due to head injury or neurological disease other than stroke, other clinical forms of aphasia, unstable cardiac dysrhythmia or cardiac pacemaker, unstable or critically ill patients, current or history of epilepsy, skull wounds and pregnant females. Also patients with severe grade of weakness which interfere with writing ability.
The severity of aphasia was assessed for every patient using the Aphasia Severity Rating Scale (ASRS). According to this scale, language deficits were recognized ranging from 0 to 5 points.Every patient was then assessed for linguistic deficits using Kasr El-Eini Arabic Aphasia test (KAAT), which is a simple, rapid, standardized, valid, and reliable bedside test for Egyptian patients, literate and illiterate.
Neuroimaging studies (computerized tomography (CT) and/or magnetic resonance imaging (MRI) of the brain) were done for all participants.
Treatment procedures:
Real rTMS was applied three times per week for 10 sessions. Fifty trains of 10-Hz stimulation, each lasting for 5 seconds with an intertrain interval of 15 seconds were given through a figure-of-8 coil (9-cm diameter loop) positioned over the left Broca's area of the affected hemisphere (25 trains over pars triangularis followed by 25 trains over pars opercularis.The intensity of stimulation was set at 80% of the resting motor threshold (rMT) for the first dorsal interosseous of unaffected hemisphere.Two parts of Broca's area were sequentially stimulated: the anterior part (pars triangularis-PTr) and the posterior part (pars opercularis-POp). To target the regions of interest precisely, the coil was positioned on the scalp according to the coordinates used by Gough et al.The anterior stimulation site was 2.5 cm posterior to the canthus along the canthus-tragus line and 3 cm superior to this line; the posterior stimulation site was 4.5 cm posterior and 6 cm superior to the canthus-tragus line. The stimulation was applied in the same session with 1000 pulses over pars triangularis followed by 1000 pulses over pars opercularis in left hemisphere.All patients were evaluated before, after the end of last session of rTMS and after one month with ASRS and KAAT. The outcome measures were collected and statistically analyzed
- Conditions
- Post Stroke Aphasia
- Being tested
- rTMS (repetitive transcranial magnetic stimulation )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMS (repetitive transcranial magnetic stimulation )Device
applying high frequency TMS over the damaged hemisphere in chronic post stroke aphasic patients
| Study group | Role | What they receive |
|---|---|---|
| aphasic patients | Other | post stroke aphasic patients will receive 10 sessions of high frequency rTMS 3 times per week over the damaged hemisphere without language therapy Receives: Device: rTMS (repetitive transcranial magnetic stimulation ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the recovery of post stroke aphasia by non invasive procedure without language therapy
rTMs is non invasive procedure may help improvement of speech performance
Measured: 1 month to assess the recovery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2021
- Study start1 Jun 2020
- Primary completion1 Feb 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post Stroke AphasiaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haidy Elshebawy, Cairo University
- Investigators
- Haidy Elshebawy, lecturer, Principal investigator, El kasr al ainy hospitals ,faculty of medicine ,cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04708197
- Sponsor's protocol ID
- Shebawy12345
- Status last verified
- Aug 2021
- First submitted
- 9 Jan 2021
- Last updated
- 6 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fahmy EM, Elshebawy HM. Effect of High Frequency Transcranial Magnetic Stimulation on Recovery of Chronic Post-Stroke Aphasia. J Stroke Cerebrovasc Dis. 2021 Aug;30(8):105855. doi: 10.1016/j.jstrokecerebrovasdis.2021.105855. Epub 2021 May 25.
PubMed 34049013
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of rTMS in Recovery of Chronic Post Stroke Aphasia
- ClinicalTrials.gov ID
- NCT04708197
- Acronym / sponsor ID
- Shebawy12345
- Conditions
- Post Stroke Aphasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 13 Jan 2021 (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.
high frequency excitatory rTMS applied over the dominant hemisphere in chronic post stroke aphasic patients to help the restoration of function by the left hemisphere
Detailed description
Repetitive transcranial magnetic stimulation (rTMS) has been used in many studies as a novel intervention to treat disorders associated with stroke, including paralysis or dysphagia, hemispatial neglect, pain, and aphasia. Number of studies have demonstrated that low-frequency rTMS over the unaffected hemisphere can be useful for enhancing recovery in aphasic patients.. It is expected that application of high-frequency (facilitatory) rTMS over the dominant speech area would have a beneficial effect on improving speech performance.
The aim of this study is to evaluate the effect of excitatory high frequency rTMS on recovery of aphasia in chronic aphasic patients due to cerebrovascular stroke. Twenty patients with post-stroke aphasia were enrolled in this study. Patients were selected from those attending the stroke clinic of Neurology department, Cairo University during the period from June 2020 to November 2020. The protocol of the study was approved by the ethical committee of the Department of Neurology, Faculty of Medicine, Cairo University. The aim and procedures of the study were explained and written consent forms were taken from all patients prior to participation.
The eligibility criteria were: chronic post stroke nonfluent aphasia due to first-ever ischemic stroke in the distribution of middle cerebral artery diagnosed clinically and documented by computed tomography or magnetic resonance imaging on the brain, right handedness, both sexes, age ranged from 33 to 66 years old, duration at least 4 months from stroke onset, patients not receiving speech therapy and educated at least 10 years of education.
Exclusion criteria were: aphasia due to head injury or neurological disease other than stroke, other clinical forms of aphasia, unstable cardiac dysrhythmia or cardiac pacemaker, unstable or critically ill patients, current or history of epilepsy, skull wounds and pregnant females. Also patients with severe grade of weakness which interfere with writing ability.
The severity of aphasia was assessed for every patient using the Aphasia Severity Rating Scale (ASRS). According to this scale, language deficits were recognized ranging from 0 to 5 points.Every patient was then assessed for linguistic deficits using Kasr El-Eini Arabic Aphasia test (KAAT), which is a simple, rapid, standardized, valid, and reliable bedside test for Egyptian patients, literate and illiterate.
Neuroimaging studies (computerized tomography (CT) and/or magnetic resonance imaging (MRI) of the brain) were done for all participants.
Treatment procedures:
Real rTMS was applied three times per week for 10 sessions. Fifty trains of 10-Hz stimulation, each lasting for 5 seconds with an intertrain interval of 15 seconds were given through a figure-of-8 coil (9-cm diameter loop) positioned over the left Broca's area of the affected hemisphere (25 trains over pars triangularis followed by 25 trains over pars opercularis.The intensity of stimulation was set at 80% of the resting motor threshold (rMT) for the first dorsal interosseous of unaffected hemisphere.Two parts of Broca's area were sequentially stimulated: the anterior part (pars triangularis-PTr) and the posterior part (pars opercularis-POp). To target the regions of interest precisely, the coil was positioned on the scalp according to the coordinates used by Gough et al.The anterior stimulation site was 2.5 cm posterior to the canthus along the canthus-tragus line and 3 cm superior to this line; the posterior stimulation site was 4.5 cm posterior and 6 cm superior to the canthus-tragus line. The stimulation was applied in the same session with 1000 pulses over pars triangularis followed by 1000 pulses over pars opercularis in left hemisphere.All patients were evaluated before, after the end of last session of rTMS and after one month with ASRS and KAAT. The outcome measures were collected and statistically analyzed
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aphasic patients | Other | Device: rTMS (repetitive transcranial magnetic stimulation )post stroke aphasic patients will receive 10 sessions of high frequency rTMS 3 times per week over the damaged hemisphere without language therapy |
Who may qualify
- Ages
- 33 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- chronic post stroke nonfluent aphasia due to first-ever ischemic stroke in the distribution of middle cerebral artery diagnosed clinically and documented by computed tomography or magnetic resonance imaging on the brain
- Right handedness
- Both sexe groups
- Age ranged from 33 to 66 years old,
- Duration is at least 4 months from stroke onset,
Key exclusion criteria (5 listed)
- Aphasia due to head injury or neurological disease other than stroke,
- unstable cardiac dysrhythmia or cardiac pacemaker
- unstable or critically ill patients
- current or history of epilepsy, skull wounds and pregnant females.
- patients with severe grade of weakness which interfere with writing ability.
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 |
|---|---|---|
| rTMS (repetitive transcranial magnetic stimulation )applying high frequency TMS over the damaged hemisphere in chronic post stroke aphasic patients | Device | aphasic patients |
Primary outcome
evaluate the recovery of post stroke aphasia by non invasive procedure without language therapy
Time frame: 1 month to assess the recovery
rTMs is non invasive procedure may help improvement of speech performance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2021.
- Derived from this study: PubMed 34049013Fahmy EM, Elshebawy HM. Effect of High Frequency Transcranial Magnetic Stimulation on Recovery of Chronic Post-Stroke Aphasia. J Stroke Cerebrovasc Dis. 2021 Aug;30(8):105855. doi: 10.1016/j.jstrokecerebrovasdis.2021.105855. Epub 2021 May 25.
- Individual participant dataSharing planned: No
Related trials for Post Stroke Aphasia
Not yet recruiting
Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
Aphasia, ALS
Not yet recruiting
Cerebellar Brain Stimulation Plus Language Therapy for People at Risk of Poor Aphasia Recovery After Stroke
Aphasia, Stroke
Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Recruiting
Music Therapy for Rehabilitation in Post-stroke Non-fluent Aphasia: the Indian Adaptation
Stroke Rehabilitation, Aphasia, Broca
Recruiting
Sensory-Motor Integration for Speech Rehabilitation in Patients With Post-stroke Aphasia
Aphasia Non Fluent, Stroke
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. This study is not recruiting at the moment.
Haidy Elshebawy, lecturer principal investigator
El kasr al ainy hospitals ,faculty of medicine ,cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS (repetitive transcranial magnetic stimulation ) in people with Post Stroke Aphasia, run by Cairo University at 1 site in Egypt.
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 7 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: finished, as of the sponsor's last update on 6 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the recovery of post stroke aphasia by non invasive procedure without language therapy (time frame: 1 month to assess the recovery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04708197, which also lists 1 linked publication.
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 6 Aug 2021.