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Behavioral Intervention

tDCS + mCILT for Primary Progressive Aphasia

N/A
Recruiting
Led By Roy Hamilton, MS
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Presence of aphasia attributable to the semantic variant (svPPA) or non-fluent/agrammatic variant (naPPA) of Primary Progressive Aphasia
Must be a native English speaker
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 24 weeks
Awards & highlights

Study Summary

This trial will study the effects of transcranial direct current stimulation (tDCS) on people with primary progressive aphasia, a degenerative neurological disorder that affects language abilities. The study will use tDCS paired with modified constraint-induced language therapy (mCILT). Language testing and brain imaging will be repeated after treatment to study changes in language performance and brain activity.

Who is the study for?
This trial is for native English speakers with a specific language disorder called Primary Progressive Aphasia, either the semantic or non-fluent/agrammatic variant. It's not suitable for people with pacemakers, history of small vessel disease, other neurological disorders like stroke or Parkinson's, seizures, metallic objects in the head (except dental work), or those who've had skull surgery.Check my eligibility
What is being tested?
The study tests if brain stimulation using tDCS combined with a type of language therapy (mCILT) can help improve speech in people with PPA. Participants will receive real or fake tDCS over 10 days and have their language skills and brain function assessed before and after treatment, up to 24 weeks later.See study design
What are the potential side effects?
tDCS may cause mild side effects such as itching, tingling at the electrode site during application, headache, fatigue or nausea. However, these are typically temporary and resolve soon after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with a specific type of language disorder due to Primary Progressive Aphasia.
Select...
I am a native English speaker.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Western Aphasia Battery (WAB)

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: tDCS + CILTActive Control2 Interventions
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of tDCS for 20 minutes using a montage in which an anode (1.5 mA) is placed over F7 (left frontotemporal lobe) and the cathode will be place on O1 (left occipital) using the 10-20 EEG mapping system. Subjects will participate in a modified constraint-induced language therapy.
Group II: Sham tDCS + CILTPlacebo Group2 Interventions
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of sham tDCS for 20 minutes using a montage in which an anode is placed of F7 and cathose is placed over O1. Subjects will participate in a modified constraint-induced language therapy,

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor
2,005 Previous Clinical Trials
42,882,147 Total Patients Enrolled
Roy Hamilton, MSPrincipal InvestigatorUniversity of Pennsylvania

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For whom is this investigation best suited?

"This clinical trial is looking for 62 individuals aged between 45 and 80 who are affected by aphasia. In particular, candidates must meet the criteria of either semantic variant (svPPA) or non-fluent/agrammatic variant (naPPA) Primary progressive aphasia."

Answered by AI

What is the scope of participation in this clinical investigation?

"Correct. According to clinicaltrials.gov, the trial which was advertised on December 1st 2020 is actively recruiting participants at this moment in time. This study requires 62 volunteers from a single location for its completion."

Answered by AI

Is there still an opportunity for enrolment in this research study?

"Affirmative. Clinicaltrials.gov holds the details of this medical trial, which was initially posted on December 1st 2020 and recently modified on January 28th 2022, showing that it is actively recruiting 62 patients from a single site."

Answered by AI

Does this research endeavor accept participants who have reached the age of 55 or greater?

"This clinical trial is accepting patients who have surpassed their mid-forties yet are still under eighty years old."

Answered by AI

Who else is applying?

What site did they apply to?
University of Pennsylvania
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~3 spots leftby Jul 2024