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NCT03406429 · ClinicalTrials.gov registry record · Early Phase 1

rTMS as a Treatment for PPA

A Early Phase 1 study, sponsored by Massachusetts General Hospital.

Completed
Registry status
Early Phase 1
Development phase
12
Enrollment target

NCT03406429: Completed Early Phase 1 study, sponsored by Massachusetts General Hospital.

NCT03406429 is a Early Phase 1 study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 12 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03406429, a Early Phase 1 study, has completed, sponsored by Massachusetts General Hospital.

COMPLETED
Registry status
Early Phase 1
Development phase
12 participants
Enrollment target

Study Summary

Primary progressive aphasia (PPA) includes three variants. Two such variants, the non-fluent/agrammatic variant (nfvPPA) and the logopenic variant (lvPPA), are characterized by progressive word-finding difficulties and effortful speech. Efforts to slow or halt this progression have been largely unsuccessful. As such, there is a desperate need for novel treatment strategies in PPA. Repetitive transcranial magnetic stimulation (rTMS) is a safe, non-invasive way of stimulating cortical targets in a focal and reproducible manner. Therapeutic benefits from rTMS have been demonstrated when it is applied in many sequential sessions. For example, repeated sessions of rTMS to left dorsolateral prefrontal cortex (dlPFC) is approved by the US Food and Drug administration as a treatment for major depressive disorder. With respect to language, high frequency rTMS increases the response rate for picture naming in healthy individuals. rTMS has also been shown to improve the number of correct naming responses in patients with Alzheimer's disease. Further, in a sham controlled study, Cotelli and colleagues demonstrated that in a group of 10 nfvPPA patients high frequency rTMS over the left and right dlPFC during object and action naming tasks improved the percent of correct responses for action, but not object naming. Finally, in a sham controlled single case study, Finocchiaro et al. applied high frequency rTMS to the left inferior mid-frontal gyrus for 3 sessions consisting of five consecutive days (treatment or sham). They found a significant and lasting improvement in the patient's performance on verb production when comparing active rTMS to sham rTMS or baseline. These studies have contributed valuable insights into the potential use of rTMS in treating the language symptoms of PPA patients.

Primary Outcome

This will include tests of speech production, confrontation naming, sentence completion.

Interventions

  • DEVICE Active rTMS
  • DEVICE SHAM rTMS

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2019-12-01
Est. Completion 2022-01-01
Phase Early Phase 1
Massachusetts General Hospital

2,032 total trials

What the finished NCT03406429 record still lists

NCT03406429 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (77% lower).

The record links to 0 conditions, and to 2 interventions - of which Active rTMS is the first listed.

NCT03406429 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03406429 about?

NCT03406429 is a clinical study titled "rTMS as a Treatment for PPA". Primary progressive aphasia (PPA) includes three variants. Two such variants, the non-fluent/agrammatic variant (nfvPPA) and the logopenic variant (lvPPA), are characterized by progressive word-finding difficulties and effortful speech. Efforts to slow or halt this progression have been largely unsu...

What is the current status of trial NCT03406429?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2019-12-01. Estimated completion is 2022-01-01.

What interventions are being tested in trial NCT03406429?

The interventions under investigation include: Active rTMS (DEVICE), SHAM rTMS (DEVICE).

Who is sponsoring clinical trial NCT03406429?

This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03406429's enrollment target sits among peer trials

12 1529th of 2000 higher than 401 of 2,000 other Early Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03406429, the US trial registry maintained by the National Library of Medicine. NCT03406429 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.