NCT04708197

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 13, 2021

Completed
19 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

August 6, 2021

Status Verified

August 1, 2021

Enrollment Period

8 months

First QC Date

January 9, 2021

Last Update Submit

August 2, 2021

Conditions

Outcome Measures

Primary Outcomes (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

    1 month to assess the recovery

Study Arms (1)

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

Device: rTMS (repetitive transcranial magnetic stimulation )

Interventions

applying high frequency TMS over the damaged hemisphere in chronic post stroke aphasic patients

aphasic patients

Eligibility Criteria

Age33 Years - 66 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haidy Elshebawy

Cairo, 11931, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Haidy Elshebawy, lecturer

    El kasr al ainy hospitals ,faculty of medicine ,cairo university

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer of Neurology ,MD ,faculty of medicine ,Cairo University

Study Record Dates

First Submitted

January 9, 2021

First Posted

January 13, 2021

Study Start

June 1, 2020

Primary Completion

February 1, 2021

Study Completion

May 1, 2021

Last Updated

August 6, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations