Logopenic Progressive AphasiaNCT04193267
Can Magnetic Brain Stimulation Improve Language Function in Primary Progressive Aphasia
A study testing MagStim Rapid2 Transcranial Magnetic Simulation in people with Logopenic Progressive Aphasia, run by University of Manitoba at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Logopenic Progressive Aphasia
- What is being tested?
- MagStim Rapid2 Transcranial Magnetic Simulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2020to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St. Boniface Hospital
Winnipeg, Manitoba, R2H2A6
Benjamin Meek, 2042372677, rtms@sbgh.mb.ca
About this study
Official title: rTMS for the Improvement of Language Functioning in the Logopenic Variant of Primary Progressive Aphasia; a Feasibility and Tolerability Pilot Study
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.
Read the 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.
- Conditions
- Logopenic Progressive Aphasia
- Being tested
- MagStim Rapid2 Transcranial Magnetic Simulation
- Keywords
- Primary Progressive Aphasia, Brain Stimulation
- Medical subject headings
- Aphasia, Primary Progressive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagStim Rapid2 Transcranial Magnetic SimulationDevice
A non-invasive method of brain stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MagStim Rapid2 Transcranial Magnetic Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One week pre- and one week post-rTMS treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Jun 2020
- Primary completionAug 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Logopenic Progressive AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Tsang, MD, Principal investigator, University of ManitobaMandana Modirrousta, MD PhD, Study director, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04193267
- Sponsor's protocol ID
- HS23339 (B2019:108)
- Status last verified
- Mar 2021
- First submitted
- 18 Nov 2019
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- rTMS for the Improvement of Language Functioning in the Logopenic Variant of Primary Progressive Aphasia; a Feasibility and Tolerability Pilot Study
- ClinicalTrials.gov ID
- NCT04193267
- Acronym / sponsor ID
- HS23339 (B2019:108)
- Conditions
- Logopenic Progressive Aphasia
- Keywords
- Primary Progressive Aphasia, Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 10 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Repetitive Transcranial Magnetic Stimulation (rTMS) | Experimental | Device: MagStim Rapid2 Transcranial Magnetic Simulation30 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MagStim Rapid2 Transcranial Magnetic SimulationA non-invasive method of brain stimulation | Device | Repetitive Transcranial Magnetic Stimulation (rTMS) |
Primary outcome
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. Minimum score = 0. Maximum score = 24. Higher scores indicate better naming performance.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Tsang, MD principal investigator
University of Manitoba
Mandana Modirrousta, MD PhD study director
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MagStim Rapid2 Transcranial Magnetic Simulation in people with Logopenic Progressive Aphasia, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Benjamin Meek (2042372677, rtms@sbgh.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in score on the Druks and Masterson Naming Task (time frame: One week pre- and one week post-rTMS treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2021.