Remotely Supervised tDCS and Word-Naming Practice for Primary Progressive Aphasia

NYU Langone Health, New York, NY
Primary Progressive AphasiaTranscranial Direct Current Stimulation (tDCS) - Device
Eligibility
45 - 80
All Sexes

Study Summary

This trial will evaluate if a combination of remotely supervised brain stimulation and language skills practice can help people living with PPA. No established treatments exist.

Eligible Conditions
  • Primary Progressive Aphasia

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Baseline, Month 6

Baseline, Month 6
Change in Aphasia Communication Outcome Measure (ACOM) Score
Change in Boston Naming Test (BNT)-Short form Score
Change in Controlled Oral Word Association Test (COWAT) Score
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health Score
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities Score
Aphasia Tests
Aphasia
Week 4
Number of Trained Language Probes at Treatment End
Number of Untrained Language Probes at Treatment End
Percentage of Participants who Complete 16 out of 20 Study Visits

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Remotely Supervised tDCS and Word-Naming Practice
1 of 1

Experimental Treatment

30 Total Participants · 1 Treatment Group

Primary Treatment: Remotely Supervised tDCS and Word-Naming Practice · No Placebo Group · Phase 2

Remotely Supervised tDCS and Word-Naming PracticeExperimental Group · 2 Interventions: Transcranial Direct Current Stimulation (tDCS), Word-Naming Activity · Intervention Types: Device, Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation (tDCS)
2016
Completed Phase 2
~2090

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, month 6

Who is running the clinical trial?

NYU Langone HealthLead Sponsor
1,306 Previous Clinical Trials
761,725 Total Patients Enrolled
Leigh Charvet, PhDPrincipal InvestigatorNYU Langone Health
4 Previous Clinical Trials
116 Total Patients Enrolled

Eligibility Criteria

Age 45 - 80 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
New York100.0%
What site did they apply to?
NYU Langone Health100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
How many prior treatments have patients received?
0100.0%

Frequently Asked Questions

Is this clinical experiment open to individuals aged 55 and above?

"This medical trial's eligibility criteria necessitates that applicants be between 45 and 80 years old." - Anonymous Online Contributor

Unverified Answer

Who is eligible to take part in this research initiative?

"This clinical trial is searching for 30 participants with primary progressive aphasia (PPA) between 45 and 80 years old. To be eligible, they must have a PPVT score that falls below -1 standard deviation, WAIS-IV Matrix Reasoning T score lower than 20, English language fluency sufficient to take part in the study procedures, stable internet access and email service (WiFi "hotspot" provided if necessary), diagnosis of PPA's logopenic or semantic variant." - Anonymous Online Contributor

Unverified Answer

How many participants are receiving treatment through this investigation?

"Affirmative. According to the clinicaltrials.gov website, this medical study is currently recruiting patients who meet its criteria - with a total of 30 needed from one site. This trial was initially posted on November 1st 2022 and most recently edited on November 8th 2022." - Anonymous Online Contributor

Unverified Answer

Has the FDA authorized Remotely Supervised tDCS and Word-Naming Practice?

"According to our team at Power's assessment, the safety of Remotely Supervised tDCS and Word-Naming Practice is estimated as a 2 due to this being a Phase 2 trial. This indicates there are some data points supporting its security but none that demonstrate efficacy." - Anonymous Online Contributor

Unverified Answer

Are there any active recruitment opportunities for this clinical trial?

"Affirmative. As per information on clinicaltrials.gov, this trial is actively welcoming patients to take part in its research. The investigation was first publicized on November 1st 2022 and has been revised most recently on the 8th of that same month. Only 30 individuals need to be enrolled from a single medical facility." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.