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Can Magnetic Brain Stimulation Improve Language Function in Primary Progressive Aphasia

Primary Purpose

Logopenic Progressive Aphasia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MagStim Rapid2 Transcranial Magnetic Simulation
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Logopenic Progressive Aphasia focused on measuring Primary Progressive Aphasia, Brain Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Boniface HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Repetitive Transcranial Magnetic Stimulation (rTMS)

Arm Description

30 sessions of high-frequency (10Hz) repetitive stimulation applied over the posterior region of the left superior temporal gyrus in patients with logopenic primary progressive aphasia (PPA-L) using a MagStim Rapid2 Transcranial Magnetic Simulation machine.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 18, 2019
Last Updated
March 19, 2021
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT04193267
Brief Title
Can Magnetic Brain Stimulation Improve Language Function in Primary Progressive Aphasia
Official Title
rTMS for the Improvement of Language Functioning in the Logopenic Variant of Primary Progressive Aphasia; a Feasibility and Tolerability Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
August 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Logopenic Progressive Aphasia
Keywords
Primary Progressive Aphasia, Brain Stimulation

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Repetitive Transcranial Magnetic Stimulation (rTMS)
Arm Type
Experimental
Arm Description
30 sessions of high-frequency (10Hz) repetitive stimulation applied over the posterior region of the left superior temporal gyrus in patients with logopenic primary progressive aphasia (PPA-L) using a MagStim Rapid2 Transcranial Magnetic Simulation machine.
Intervention Type
Device
Intervention Name(s)
MagStim Rapid2 Transcranial Magnetic Simulation
Intervention Description
A non-invasive method of brain stimulation
Primary Outcome Measure Information:
Title
Change in score on the Druks and Masterson Naming Task
Description
Assessment of change in language function as a result of rTMS intervention. Minimum score = 0. Maximum score = 24. Higher scores indicate better naming performance.
Time Frame
One week pre- and one week post-rTMS treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benjamin Meek
Phone
2042372677
Email
rtms@sbgh.mb.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Tsang, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mandana Modirrousta, MD PhD
Organizational Affiliation
University of Manitoba
Official's Role
Study Director
Facility Information:
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H2A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Meek
Phone
2042372677
Email
rtms@sbgh.mb.ca

12. IPD Sharing Statement

Plan to Share IPD
No

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Can Magnetic Brain Stimulation Improve Language Function in Primary Progressive Aphasia

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