An Early Phase 1 interventional study of Active rTMS and SHAM rTMS in Logopenic Variant Primary Progressive Aphasia and Non-Fluent Primary Progressive Aphasia, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2022-04-07.
Sponsored by Massachusetts General Hospital · Early Phase 1, Interventional, and Other
Among 13 studies in Primary Progressive Nonfluent Aphasia with a site in United States — 6 open to participants now, 7 under way, none of them phase 3. Primary Progressive Nonfluent Aphasia · United States.
Among the 13 studies in Primary Progressive Nonfluent Aphasia with a site in United States, this one is the 9th largest by enrollment of the 10 interventional ones that give a count, is the only one that started in 2019, is one of 4 in phase 1, and was the 8th registered.
20 studies on the registry are indexed under Primary Progressive Nonfluent Aphasia; 8 are open to participants now.
Browse Primary Progressive Nonfluent Aphasia studies →6 of the 13 studies in Primary Progressive Nonfluent Aphasia with a site in United States are open now. Recruiting first, the newest first:
Maya Henry · Sites in United States
Johns Hopkins University · Sites in United States, Canada
Mayo Clinic · Sites in United States
Mayo Clinic · Sites in United States
Northwestern University · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 7 Primary Progressive Nonfluent Aphasia studies recruiting now, 4 (57%) set no upper age limit and 0 (0%) stop at 75 or younger; 1 take children under 18; 3 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
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13 studies; the count open now beside each. This study's row is marked.
First in 2007; this study’s year is marked. 1 started in 2019.
This study's enrollment of 12 is below the median of 33 across 15 interventional studies indexed under Primary Progressive Nonfluent Aphasia.
Median enrollment 40 across the 10 interventional studies, 500 across the 3 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
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None of the 13 has an industry lead sponsor. The 8 most frequent:
Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Massachusetts General Hospital has 1 study filed under Primary Progressive Nonfluent Aphasia — fewer than ten, so there is no comparison to draw.
3 of the studies in Primary Progressive Nonfluent Aphasia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT00537004Northwestern UniversityLanguage in Primary Progressive Aphasia | 2027-04 |
| NCT03313011Mayo ClinicThe Neurobiology of Two Distinct Types of Progressive Apraxia of Speech | 2027-07 |
| NCT07219680Maya HenryIntervention for Communication Quality of Life in Primary Progressive Aphasia | 2027-08 |
Among the 13 studies in Primary Progressive Nonfluent Aphasia with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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.
15-20 patients with a confirmed diagnosis of either nfvPPA or lvPPA (made by a specialized clinician) will be recruited. Patients must have a mild to moderate language impairment and must be native English speakers. Exclusion criteria include contraindications to receiving Magnetic Resonance Imaging (MRI) scanning or rTMS (e.g. metallic or electromagnetically activated implants, cranial mass lesions, surgical aneurysm clips), the presence of significant medical, neurological or psychiatric co-morbid symptoms and patients without study partners.
It will take approximately 2 weeks to complete this research study, but the exact timing will vary according to patient, investigator and equipment availability. Each patient will have a total of up to 11 study visits. Greater than 11 visits may take place in the event that patients' language improves significantly following rTMS in order to test the sustainability of the improvement. Visits will take place at the MGH Martinos Center for Biomedical Imaging.
The first visit (lasting 3-4 hours) will include obtainment of informed consent, baseline assessments, and a baseline MRI scan (which will be used for subsequent rTMS targeting). After this, patients will return for two blocks of 20Hz rTMS to left dlpfc: one in which they receive active rTMS and one in which they receive sham rTMS. Both active and sham rTMS will be delivered as high frequency stimulation (20 hertz, 20Hz). To accomplish this, an rTMS coil capable of delivering active or sham stimulation will be employed. Order of active and sham blocks will be counterbalanced across participants. During each block rTMS (active or sham) will be administered daily for 5 days (Monday through Friday). Neuropsychological testing, including thorough language evaluations, will be done before and after each block of rTMS. Repeat MRI imaging will be performed at the end of each of the two blocks. rTMS visit durations will be as follows: Monday visits will last approximately 3-4 hours, Tuesday, Wednesday and Thursday visits will last approximately 1-2 hours and Friday visits will last approximately 5 hours.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All study participants will carry a diagnosis of Primary Progressive Aphasia (PPA), either the logopenic or the non-fluent variant. All participants will receive the same study interventions in a within-subject crossover design.
Device: Active rTMS · Device: SHAM rTMS
All study participants will receive one block of active rTMS. Each block will consist of daily sessions of 20Hz active rTMS delivered to the left dorsolateral prefrontal cortex (dlPFC) over five days (Monday through Friday).
All study participants will receive one block of SHAM rTMS. Each block will consist of daily sessions of 20Hz SHAM rTMS delivered to the left dorsolateral prefrontal cortex (dlPFC) over five days (Monday through Friday).
Language Assessment Battery
This will include tests of speech production, confrontation naming, sentence completion.
Time frame: At the beginning and end of each rTMS block.
MRI Imaging
This will include observed changes in resting-state functional connectivity and cortical thickness occurring as a result of the stimulation.
Time frame: At the baseline visit and at the end of each rTMS block.
Plan to share: No
Ran from Dec 2019 to primary completion in Jan 2022, 25 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Primary Progressive Nonfluent Aphasia →
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