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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and post treatment day 10
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am between 18 and 90 years old and have been diagnosed with a specific type of speech disorder.
Select...
I am a native English speaker.
Select...
I am between 18-90 years old and have been diagnosed with a specific type of speech disorder for over a year.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in Brain Network Connectivity
Changes in Language
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
Find a Location
Who is running the clinical trial?
National Institute on Deafness and Other Communication Disorders (NIDCD)NIH
329 Previous Clinical Trials
178,320 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,932 Previous Clinical Trials
13,198,467 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have evidence of a serious brain condition seen on a special type of scan called Magnetic Resonance Imaging (MRI).I do not have any metal implants or devices that could interfere with MRI or rTMS.I have been diagnosed with a significant mental health or substance use disorder.I am between 18 and 90 years old and have been diagnosed with a specific type of speech disorder.Participants should have some difficulty with speaking and understanding language.I am not pregnant or breastfeeding.I do not have major neurological issues or unmanaged health problems like diabetes.I am a native English speaker.I am between 18-90 years old and have been diagnosed with a specific type of speech disorder for over a year.I have had seizures, unexplained fainting, or a close relative with epilepsy.
Research Study Groups:
This trial has the following groups:- Group 1: PPA patients
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Primary Progressive Aphasia Patient Testimony for trial: Trial Name: NCT04188067 — Phase < 1
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any vacancies for participants in this research endeavor?
"This medical trial, which was initially launched on March 1st 2022 and recently modified on April 4th 2022 according to clinicaltrials.gov's records, is actively recruiting for candidates."
Answered by AI
May I submit my candidacy for this clinical experiment?
"The study is in search of 30 individuals between the ages 18 to 90 that have been diagnosed with logopenic variant primary progressive aphasia. To qualify for participation, participants must be native English speakers and show at least mild to moderate language impairment, observed by an experienced clinician over one year's time. Furthermore, they need to bring a companion (like spouse or child) along during each visit."
Answered by AI
What is the participant capacity of this research endeavor?
"Correct. According to clinicaltrials.gov, the trial is recruiting as of April 4th 2022 and originally appeared on March 1st. The study aims to enlist 30 participants across a single location."
Answered by AI
Are people below a certain age permissible to join this trial?
"A pre-requisite for this clinical trial is that applicants must be between 18 and 90. Additionally, there are 11 studies specifically targeting minors while 118 other studies focus on adults over the age of 65."
Answered by AI
Who else is applying?
What state do they live in?
Connecticut
What site did they apply to?
Massachusetts General Hospital
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
2
Why did patients apply to this trial?
I suffered a stroke 11/23/22 and now I have aphasia, am going to a speech therapist 3 times a week but would like better progress. So I am willing to become part of a study.
PatientReceived 1 prior treatment
We are trying to get into clinical trials that have some form of treatment. We also have a nephew that lives in Boston. He and his wife would be helpful to us in navigating the city.
PatientReceived no prior treatments
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