Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04708197 |
| Other study ID # |
Shebawy12345 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2020 |
| Est. completion date |
May 1, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Cairo University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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
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
