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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Egypt1 site
  • Haidy Elshebawy

    Cairo, 11931

Other trials in Egypt

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

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 groups in NCT04708197
Study groupRoleWhat they receive
aphasic patientsOtherpost 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.

  1. 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.

  1. First posted13 Jan 2021
  2. Study start1 Jun 2020
  3. Primary completion1 Feb 2021
  4. Study completion1 May 2021

Resources

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)
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

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.

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