Can Magnetic Brain Stimulation Improve Language Function in Primary Progressive Aphasia

NCT04193267 | Unknown

• 1 other identifier: HS23339 (B2019:108)
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Logopenic Progressive Aphasia

Keywords

Primary Progressive Aphasia; Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Repetitive Transcranial Magnetic Stimulation (rTMS)

EXPERIMENTAL

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

Interventions

MagStim Rapid2 Transcranial Magnetic Simulation DEVICE

A non-invasive method of brain stimulation

Repetitive Transcranial Magnetic Stimulation (rTMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H2A6, Canada

RECRUITING

MeSH Terms

Conditions

Aphasia, Primary Progressive

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Michelle Tsang, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

• Mandana Modirrousta, MD PhD

  University of Manitoba

  STUDY DIRECTOR

Central Study Contacts

Benjamin Meek

CONTACT

2042372677; rtms@sbgh.mb.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2019
• First Posted: December 10, 2019
• Study Start: June 1, 2020
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)