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Can Magnetic Brain Stimulation Improve Language Function in Primary Progressive Aphasia

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ClinicalTrials.gov Identifier: NCT04193267
Recruitment Status : Not yet recruiting
First Posted : December 10, 2019
Last Update Posted : December 10, 2019
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

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.

Condition or disease Intervention/treatment Phase
Logopenic Progressive Aphasia Device: MagStim Rapid2 Transcranial Magnetic Simulation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: rTMS for the Improvement of Language Functioning in the Logopenic Variant of Primary Progressive Aphasia; a Feasibility and Tolerability Pilot Study
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : December 2022


Arm Intervention/treatment
Experimental: Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Device: MagStim Rapid2 Transcranial Magnetic Simulation
A non-invasive method of brain stimulation




Primary Outcome Measures :
  1. Change in score on the Druks and Masterson Naming Task [ Time Frame: One week pre- and one week post-rTMS treatment ]
    Assessment of change in language function as a result of rTMS intervention



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04193267


Contacts
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Contact: Benjamin Meek 2042372677 rtms@sbgh.mb.ca

Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Michelle Tsang, MD University of Manitoba
Study Director: Mandana Modirrousta, MD PhD University of Manitoba
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Responsible Party: University of Manitoba
ClinicalTrials.gov Identifier: NCT04193267    
Other Study ID Numbers: HS23339 (B2019:108)
First Posted: December 10, 2019    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Manitoba:
Primary Progressive Aphasia
Brain Stimulation
Additional relevant MeSH terms:
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Aphasia
Aphasia, Primary Progressive
Pick Disease of the Brain
Frontotemporal Dementia
Speech Disorders
Language Disorders
Communication Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Dementia
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Frontotemporal Lobar Degeneration
TDP-43 Proteinopathies
Neurodegenerative Diseases
Proteostasis Deficiencies
Metabolic Diseases