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Behavioural Intervention

TMS for Primary Progressive Aphasia

Phase < 1

Recruiting

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients, age 18-90, who carry a diagnosis of either the logopenic (lvPPA), agrammatic non-fluent (nfvPPA) or semantic (svPPA) variants of Primary Progressive Aphasia (PPA).

Patients must be native English speakers.

Must not have

Contraindications to MRI or repetitive transcranial magnetic stimulation (rTMS) including: cardiac pacemaker or pacemaker wires, neurostimulators, implanted pumps, metal in the body (rods, plates, screws, shrapnel, dentures, intrauterine device), surgical aneurysm clips in the head, previous neurosurgery or cochlear implants.

Active symptoms of major depressive disorder, bipolar disorder, schizophrenia, substance use disorder or significant premorbid intellectual disability according to Diagnostic Statistical Manual (DSM-5) criteria.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and post treatment day 10

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether non-invasive repetitive transcranial brain stimulation (rTMS), which induces electric currents in degenerating brain networks, can help people with Primary Progressive Aphasia (PPA), a progressive syndrome in the family of Alzheimer's disease and related disorders involving devastating language impairments caused by selective neurodegeneration of the brain's language network.

Who is the study for?

This trial is for adults aged 18-90 with a diagnosis of logopenic, non-fluent, or semantic variants of Primary Progressive Aphasia (PPA). Participants must have been observed by a specialist for at least one year, have mild to moderate language impairment, be native English speakers, and have a study partner. Excluded are those with certain mental health issues, seizure history, significant brain abnormalities on MRI, major neurological or medical conditions unrelated to PPA.

What is being tested?

The trial tests repetitive transcranial magnetic stimulation (rTMS), which may improve language function in PPA patients. It involves applying electric currents to the brain's language network through the scalp. The study compares active rTMS treatment against sham (placebo) rTMS to assess its effectiveness in enhancing language abilities.

What are the potential side effects?

While not explicitly mentioned here, common side effects of rTMS can include headache or discomfort at the stimulation site. There might also be risks like seizures or hearing problems if proper precautions aren't taken during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 90 years old and have been diagnosed with a specific type of speech disorder.

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I am a native English speaker.

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I am between 18-90 years old and have been diagnosed with a specific type of speech disorder for over a year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any metal implants or devices that could interfere with MRI or rTMS.

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I have been diagnosed with a significant mental health or substance use disorder.

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I do not have major neurological issues or unmanaged health problems like diabetes.

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I have had seizures, unexplained fainting, or a close relative with epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and post treatment day 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and post treatment day 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and post treatment day 10 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in Brain Network Connectivity

Changes in Language

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: PPA patientsExperimental Treatment2 Interventions

All study participants will carry a diagnosis of Primary Progressive Aphasia (PPA), either the logopenic, the non-fluent variant or the semantic variant. All participants will receive the same study interventions in a within-subject crossover design.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SHAM rTMS

2011

Completed Early Phase 1

~30

0 / 7Eligibility criteria met