Transmagnetic Stimulation Pilot in Primary Progressive Aphasia

Not Applicable

Completed

• Conditions: Primary Progressive Aphasia
• Interventions: Device: Intermittent theta burst stimulation

• Registration Number: NCT05860647
• Lead Sponsor: HealthPartners Institute

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-05
• Study First Posted: 2023-05-16
• Study Start: 2023-10-02
• Status Verified: 2024-04
• Primary Completion: 2024-05-03
• Study Completion: 2024-05-03
• Last Update Submitted: 2024-05-03
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intermittent theta burst stimulation	Intermittent theta burst stimulation	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.

Primary Outcome Measures

Name	Time	Method
Connectivity measures of the left TGd, 55b, and STV parcellations at baseline and post-treatment	6 weeks	The difference and corresponding 95% confidence interval between follow-up and baseline connectivity measures of the TGd parcellations. Range: -1 to 1.; Positive values indicate areas where connectivity is higher than healthy controls from the Human Connectome Project.

Trial Locations

Locations (1)

HealthPartners Neuroscience Center; 🇺🇸 Saint Paul, Minnesota, United States