Clinical trial NCT05860647: Transmagnetic Stimulation Pilot in Primary Progressive Aphasia
Official title: A Single Arm Study of Resting State Functional Magnetic Resonance Imaging (Rs-fMRI)-Guided Theta Burst Stimulation (TBS) in Primary Progressive Aphasia (PPA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Progressive Aphasia
Keywords: transmagnetic stimulation
functional MRI guided Theta Burst Stimulation
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
First posted: 2023-05-16
Enrollment: 3
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Frontotemporal degeneration (FTD) is a non-Alzheimer's dementia that is the 2nd most common cause of dementia in the United States. FTD may present with focal language symptoms that are clinically described as primary progressive aphasia (PPA). There are two types of PPA associated with FTD-semantic variant primary progressive aphasia (SV-PPA) and nonfluent/agrammatic variant primary progressive aphasia (NFV-PPA). Both diseases are progressive neurodegenerative disease processes that compromise dominant hemisphere large scale brain network function, ultimately resulting in mutism. There are currently no FDA-approved treatments for PPA and management is mostly supportive. In combination with resting state functional MRI (rs-fMRI), transcranial magnetic stimulation (TMS) with intermittent theta burst stimulation (iTBS) offers a non-invasive alternative to pharmacotherapy in persons with PPA. In our prior studies of Alzheimer's disease (AD) and Lewy body Dementia (LBD) subjects, investigators have determined that the anterior temporal pole (area TGd and TGv) is an area that is commonly dysfunctional in dementia. The investigators have already embarked upon an fMRI guided study of iTBS in early stage Alzheimer's disease where subjects received a series of 5 treatments to distinct brain regions inclusive of area TGd. The investigators propose a case study of 3 PPA studies where rs-fMRI is applied to the large-scale language networks.


Eligibility criteria: Inclusion Criteria:

1. Established diagnosis of NFV-PPA and SV-PPA based on criteria (Gorno-Tempini et al., 2011)
2. Prior brain imaging performed
3. Mini Mental Status Exam (MMSE)\>10
4. Subjects are between 40-90 years of age

Exclusion Criteria:

1. Non-FTD dementia including, but not limited to Alzheimer's, disease, Lewy body dementia, frontotemporal dementia, vascular dementia, Jakob-Creutzfeldt disease, etc.
2. Inability to tolerate rs-fMRI
3. Contraindication of rs-fMRI due to implants or metal
4. Seizure disorder

Primary outcomes:
measure: Connectivity Measures of the Left TGd, 55b, and STV Parcellations at Baseline and Post-treatment
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: HealthPartners Neuroscience Center
state: Minnesota
Study officials:
affiliation: HealthPartners Neurology
name: Michael H Rosenbloom, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: HealthPartners Neuroscience Research
name: Kashyap Bhavani, PhD,MBBS
role: PRINCIPAL_INVESTIGATOR
References: