search
Back to results

Effect of High Frequency Transcranial Magnetic Stimulation on Recovery of Chronic Post-Stroke Aphasia

Primary Purpose

Post Stroke Aphasia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
rTMS (repetitive transcranial magnetic stimulation )
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post Stroke Aphasia

Eligibility Criteria

33 Years - 66 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Haidy Elshebawy

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

aphasic patients

Arm Description

post stroke aphasic patients will receive 10 sessions of high frequency rTMS 3 times per week over the damaged hemisphere without language therapy

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 9, 2021
Last Updated
August 2, 2021
Sponsor
Cairo University
search

1. Study Identification

Unique Protocol Identification Number
NCT04708197
Brief Title
Effect of High Frequency Transcranial Magnetic Stimulation on Recovery of Chronic Post-Stroke Aphasia
Official Title
Role of rTMS in Recovery of Chronic Post Stroke Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
February 1, 2021 (Actual)
Study Completion Date
May 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Stroke Aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
aphasic patients
Arm Type
Other
Arm Description
post stroke aphasic patients will receive 10 sessions of high frequency rTMS 3 times per week over the damaged hemisphere without language therapy
Intervention Type
Device
Intervention Name(s)
rTMS (repetitive transcranial magnetic stimulation )
Intervention Description
applying high frequency TMS over the damaged hemisphere in chronic post stroke aphasic patients
Primary Outcome Measure Information:
Title
evaluate the recovery of post stroke aphasia by non invasive procedure without language therapy
Description
rTMs is non invasive procedure may help improvement of speech performance
Time Frame
1 month to assess the recovery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
33 Years
Maximum Age & Unit of Time
66 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haidy Elshebawy, lecturer
Organizational Affiliation
El kasr al ainy hospitals ,faculty of medicine ,cairo university
Official's Role
Principal Investigator
Facility Information:
Facility Name
Haidy Elshebawy
City
Cairo
ZIP/Postal Code
11931
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34049013
Citation
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.
Results Reference
derived

Learn more about this trial

Effect of High Frequency Transcranial Magnetic Stimulation on Recovery of Chronic Post-Stroke Aphasia

We'll reach out to this number within 24 hrs