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Behavioural Intervention
Transmagnetic Stimulation for Primary Progressive Aphasia (TMS in PPA Trial)
N/A
Waitlist Available
Led By Michael H Rosenbloom, MD
Research Sponsored by HealthPartners Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects are between 40-90 years of age
Be older than 18 years old
Must not have
Seizure disorder
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial studies a non-invasive therapy for Frontotemporal Degeneration (FTD), a type of dementia, using brain scans and magnetic stimulation. The goal is to improve symptoms and support current treatment.
Who is the study for?
This trial is for individuals aged 40-90 with a confirmed diagnosis of nonfluent/agrammatic or semantic variant primary progressive aphasia. They must have had prior brain imaging and a Mini Mental Status Exam score over 10. Those with other types of dementia, seizure disorders, or who can't undergo fMRI due to implants/metal are excluded.
What is being tested?
The study tests intermittent theta burst stimulation (iTBS), a non-invasive treatment using transcranial magnetic stimulation aimed at improving language functions in people with primary progressive aphasia by targeting specific brain regions.
What are the potential side effects?
While the description doesn't list side effects, iTBS is generally considered safe but may cause discomfort at the stimulation site, headache, lightheadedness, or temporary hearing changes during the procedure.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 40 and 90 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a seizure disorder.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Connectivity measures of the left TGd, 55b, and STV parcellations at baseline and post-treatment
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intermittent theta burst stimulationExperimental Treatment1 Intervention
All subjects will receive treatment with intermittent theta burst stimulation (iTBS). There will be a total of 5 treatments over a 2-week period. All subjects will receive iTBS to the right TGd region. TBS treatment will also be provided for two additional sites within the large-scale brain networks (LSBNs) that is found to contain the greatest number of connectivity anomalies. Total participation will be 8-10 weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Intermittent theta burst stimulation
2022
Completed Phase 2
~160
Find a Location
Who is running the clinical trial?
HealthPartners InstituteLead Sponsor
194 Previous Clinical Trials
3,721,404 Total Patients Enrolled
Michael H Rosenbloom, MDPrincipal InvestigatorHealthPartners Neurology
8 Previous Clinical Trials
228 Total Patients Enrolled
Kashyap Bhavani, PhD,MBBSPrincipal InvestigatorHealthPartners Neuroscience Research
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition is a type of dementia, but not FTD.You can't have a brain scan using rs-fMRI because you have metal implants that could be affected by the scan.I have a seizure disorder.I am between 40 and 90 years old.You are unable to tolerate resting-state functional magnetic resonance imaging (rs-fMRI).You have been diagnosed with a specific type of language disorder according to specific medical criteria.Your score on the Mini Mental Status Exam (MMSE) is higher than 10.
Research Study Groups:
This trial has the following groups:- Group 1: Intermittent theta burst stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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