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OpenTrials
Completed

NCT Number: NCT05860647

Transmagnetic Stimulation Pilot in Primary Progressive Aphasia

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Intermittent Theta Burst Stimulation

Device

MagVenture TMS Therapy with theta burst stimulation. Resting motor threshold: 80%; Number of pulses per session: 1200 pulses; Inter-train interval: 8 seconds; Pulse frequency in burst: 50 Hertz

Other names: Transmagnetic stimulation, MagVenture

Primary outcomes

  1. Connectivity Measures of the Left TGd, 55b, and STV Parcellations at Baseline and Post-treatment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Official study title

A Single Arm Study of Resting State Functional Magnetic Resonance Imaging (Rs-fMRI)-Guided Theta Burst Stimulation (TBS) in Primary Progressive Aphasia (PPA)

Acronym: TMS in PPA

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 16, 2023
Registry last updated
Jun 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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