Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04708197
Status:
COMPLETED
Last Update Posted:
2021-08-06
First Post:
2021-01-09
Brief Title:
Effect of High Frequency Transcranial Magnetic Stimulation on Recovery of Chronic Post-Stroke Aphasia
Sponsor:
Cairo University
Organization:
Cairo University
Study Overview
Official Title:
Role of rTMS in Recovery of Chronic Post Stroke Aphasia
Status:
COMPLETED
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 pointsEvery 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 andor 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 Brocas area of the affected hemisphere 25 trains over pars triangularis followed by 25 trains over pars opercularisThe intensity of stimulation was set at 80 of the resting motor threshold rMT for the first dorsal interosseous of unaffected hemisphereTwo parts of Brocas 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 alThe anterior stimulation site was 25 cm posterior to the canthus along the canthus-tragus line and 3 cm superior to this line the posterior stimulation site was 45 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 hemisphereAll 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
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 pointsEvery 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 andor 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 Brocas area of the affected hemisphere 25 trains over pars triangularis followed by 25 trains over pars opercularisThe intensity of stimulation was set at 80 of the resting motor threshold rMT for the first dorsal interosseous of unaffected hemisphereTwo parts of Brocas 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 alThe anterior stimulation site was 25 cm posterior to the canthus along the canthus-tragus line and 3 cm superior to this line the posterior stimulation site was 45 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 hemisphereAll 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None