NCT05860647: TMS in PPA

Transmagnetic Stimulation Pilot in Primary Progressive Aphasia

Completed NA Results posted Last updated 3 June 2025

What this trial tests

NA trial testing Intermittent theta burst stimulation in Primary Progressive Aphasia in 3 participants. Completed in 3 May 2024.

Timeline

2 October 2023

Primary endpoint
3 May 2024

3 May 2024

Quick facts

Lead sponsor	HealthPartners Institute
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	3
Start date	2 October 2023
Primary completion	3 May 2024
Estimated completion	3 May 2024
Sites	1 location across United States

Drugs / interventions tested

• Intermittent theta burst stimulation

Conditions studied

• Primary Progressive Aphasia — all drugs for Primary Progressive Aphasia →

Sponsor

HealthPartners Institute

Who can join

Adults 40 to 90, any sex, with Primary Progressive Aphasia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

L55b

Group	Value	95% CI
Intermittent Theta Burst Stimulation	-.06	-.07 – -.04

LTgD

Group	Value	95% CI
Intermittent Theta Burst Stimulation	.03	.02 – .05

LSTV

Group	Value	95% CI
Intermittent Theta Burst Stimulation	-.01	-.02 – .01

Change in Abnormal Connections of Parcellations Secondary · 6 weeks

Assessed by calculating the difference and standard deviation between follow-up and baseline of number of abnormal connections of the parcellations. Range: 0-378. There are 378 possible connections of the parcellation. Higher values indicate more abnormal connections of the parcellation pre and post-treatment. The change in the number of abnormal connections of the parcellation is reported.

L55b

Group	Value	95% CI
Intermittent Theta Burst Stimulation	7	± 13.7

LTgD

Group	Value	95% CI
Intermittent Theta Burst Stimulation	2	± 7

LSTV

Group	Value	95% CI
Intermittent Theta Burst Stimulation	3.6	± 10.7

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 month. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intermittent Theta Burst Stimulation

Serious: 0/3 (0%)

Deaths: 0/3

Other adverse events (2 terms — click to expand)

Reaction	System	Intermittent Theta Burst S…
Facial Twitching	Musculoskeletal and connective tissue disorders	—
Headache	Nervous system disorders	—

Data from ClinicalTrials.gov NCT05860647 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.