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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04193267
Other study ID # HS23339 (B2019:108)
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 1, 2020
Est. completion date December 2022

Study information

Verified date March 2021
Source University of Manitoba
Contact Benjamin Meek
Phone 2042372677
Email rtms@sbgh.mb.ca
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate the feasibility of using repetitive transcranial magnetic stimulation (rTMS) - a form of non-invasive brain stimulation - to improve language functioning in individuals who have the logopenic variant of primary progressive aphasia (PPA-L) - a slowly progressive impairment of language, characterized by difficulties with word-finding, sentence repetition and sentence comprehension.


Description:

This study is an open label pilot study that aims to recruit 10 individuals with diagnosed logopenic primary progressive aphasia (PPA-L) to investigate the tolerability and efficacy of using repetitive transcranial magnetic stimulation (rTMS) to improve language functioning in this disorder. rTMS is a non-invasive method of brain stimulation that uses rapid magnetic pulses applied over the scalp to activate neurons in a specified target location of the brain. A variety of language tests will be administered to participants prior to rTMS treatment as well as following 30 sessions of daily rTMS. Additionally, language testing will be performed during the first session of rTMS treatment in order to assess the effect of simultaneous rTMS administration on language function. Performance on the pre- and post-treatment tests will be compared to determine the effect of rTMS treatment on language abilities. Treatment will consist of daily sessions of high frequency (10 Hz) rTMS applied over the left temporal gyrus. Patients will receive one session of rTMS per day for 30 consecutive weekdays. Each session will take approximately 45 minutes to complete. As a pilot study, this research will be used to evaluate the effect size and the feasibility of a more definitive project in the future. Both patient response and tolerability to rTMS will be analyzed.


Recruitment information / eligibility

Status Recruiting
Enrollment 10
Est. completion date December 2022
Est. primary completion date August 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of PPA-L (confirmed by a neurologist or neuropsychiatrist who has observed the patient for at least one year); - Mild to moderate language impairment as assessed by the Druks and Masterson Naming Task; - Native English speaker. Exclusion Criteria: - Cerebrovascular disorders, hydrocephalus or intra-cranial mass, documented by MRI; - History of traumatic brain injury, seizures, or another neurological disease; - Significant medical problems (e.g. poorly controlled diabetes or hypertension or cancer within the past 5 years); - Major depressive disorder, bipolar disorder, schizophrenia, substance use disorder or mental retardation according to the criteria of the DSM-IV; - Any contraindication for rTMS (e.g., implanted metal devices; cardiac pacemaker or pacemaker wires; neurostimulators; implanted pumps, metal in the body [rods, plates, screws, shrapnel, dentures, IUD] or metallic particles in the body, surgical clips in the head, previous neurosurgery, cochlear implants, prosthetic heart valves); - Currently pregnant or breastfeeding.

Study Design


Intervention

Device:
MagStim Rapid2 Transcranial Magnetic Simulation
A non-invasive method of brain stimulation

Locations

Country Name City State
Canada St. Boniface Hospital Winnipeg Manitoba

Sponsors (1)

Lead Sponsor Collaborator
University of Manitoba

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in score on the Druks and Masterson Naming Task Assessment of change in language function as a result of rTMS intervention. Minimum score = 0. Maximum score = 24. Higher scores indicate better naming performance. One week pre- and one week post-rTMS treatment
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