RightFit
RecruitingNot applicable

Remotely-supervised Neuromodulation in PPA

Investigating the Benefits of Remotely-Supervised Neuromodulation In Primary Progressive Aphasia

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Phone or video check-ins

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will: * Complete speech-language therapy sessions delivered by video visit. * Receive either active or sham tDCS that is remotely supervised and completed at home. * Complete language and cognitive testing before and after treatment. * Undergo brain imaging and other assessments to help understand treatment response."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether brain stimulation at home, with speech-language therapy by video, can improve communication. It is for adults with logopenic variant primary progressive aphasia (lvPPA), a language disorder most often caused by Alzheimer's disease. Researchers will compare real brain stimulation with sham (placebo) stimulation, with both groups getting speech-language therapy.

The goal of this clinical trial is to learn whether home-based brain stimulation combined with virtual speech-language therapy can improve communication abilities in adults with logopenic variant primary progressive aphasia (lvPPA), a language disorder most often caused by Alzheimer's disease. The main questions the study aims to answer are: * Is combining remotely supervised transcranial direct current stimulation (tDCS) with virtual speech-language therapy feasible and acceptable for people with lvPPA? * Does this combined treatment lead to improvements in communication compared to speech-language therapy with sham (placebo) stimulation? * Do individual brain characteristics help predict who benefits most from this treatment? Researchers will compare participants who receive active tDCS plus virtual speech-language therapy to participants who receive sham (placebo) tDCS plus virtual speech-language therapy to see if active brain stimulation enhances communication outcomes. Participants will: * Complete speech-language therapy sessions delivered by video visit. * Receive either active or sham tDCS that is remotely supervised and completed at home. * Complete language and cognitive testing before and after treatment. * Undergo brain imaging and other assessments to help understand treatment response.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a diagnosis of primary progressive aphasia (PPA) and its logopenic type (lvPPA).
  • Score 15 or higher on the Mini-Mental State Examination, a test of memory and thinking.
  • Have good enough hearing and vision, with aids if needed.
  • Be able to travel to the study site and have an MRI brain scan.
  • Have high-speed internet and basic skills using a computer and the internet.
  • Speak English fluently.
  • Have a study partner who can join the study, attend training at the study site before treatment, and be present for video meetings as needed.

Who can't join

  • Have speech and language problems better explained by another brain or nerve disorder.
  • Do not have a diagnosis of lvPPA.
  • Score below 15 on the memory and thinking test.
  • Do not have a study partner who can join the study.
  • Have a history of stroke, seizures, epilepsy, head or brain injury, skull surgery, or a broken skull.
  • Have a history of severe or frequent migraines, or long-term skin problems.
  • Have metal in the head, a pacemaker, an implanted heart-shock device, or another stimulation device.
  • Are pregnant, or have another condition that makes brain stimulation or an MRI unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Meets diagnostic criteria for primary progressive aphasia (PPA) * Meets diagnostic criteria for logopenic variant PPA * Attains score of 15 or higher on the Mini-Mental State Examination * Has adequate hearing and vision (with hearing or vision aids, if needed) * Is able to travel to research site and undergo MRI brain scan * Has access to high speed internet and basic experience using a computer and the internet * Is a fluent speaker of English * Has a study partner who can co-enroll in the study, attend pre-treatment training at the research site, and be present for teleconference meetings, as needed Exclusion Criteria: * Speech and language deficits better accounted for by another neurological disorder * Does not meet diagnostic criteria for logopenic variant PPA * Scores less than 15 on the Mini-Mental State Examination * Does not have a study partner who can co-enroll in the study * Has contraindications for tDCS or MRI scan (History of seizures, head injury, craniotomy, skull surgery or fracture; History of severe or frequent migraines; Metallic implant in head or any metal in head; Pacemaker or cardioverter-defibrillator or any other stimulator; Chronic skin problems; Pregnancy) * Has a history of stroke, epilepsy, or significant brain injury

Study sites (2)

CA

TX