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Primary Progressive AphasiaPhase 2NCT05615922

Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA)

A Phase 2 study testing Transcranial Direct Current Stimulation (tDCS) and Word-Naming Activity in people with Primary Progressive Aphasia, run by NYU Langone Health at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to establish the feasibility of a program of remotely supervised transcranial direct current stimulation (RS-tDCS) paired with language skills practice for people living with the semantic or logopenic variants of primary progressive aphasia (PPA). Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Primary Progressive Aphasia
What is being tested?
Transcranial Direct Current Stimulation (tDCS) and Word-Naming Activity
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
24 Dec 2022to 14 Aug 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Primary progressive aphasia diagnosis (logopenic or semantic variant)
  • Peabody Picture Vocabulary Test (PPVT) score < -1.0 SD, serving as a literacy proxy for premorbid cognitive ability and ensuring English language fluency sufficient for participation in the study procedures.
  • WAIS-IV Matrix Reasoning T score < 20, serving as an index of current general cognitive functioning to exclude those with severe cognitive impairment
  • Stable and continuous access to internet service, email (WiFi "hotspot" to be provided if needed)
  • Fluent in English language (due to outcomes validated in English versions only)

Who cannot join

  • Disorder other than PPA known to cause language dysfunction
  • Diagnosis of nonfluent/agrammatic subtype of primary progressive aphasia
  • History of traumatic brain injury
  • Uncontrolled seizure disorder and/or recent (<5 years) history of seizure
  • Metal implants in the head or neck
  • Any skin disorder or skin sensitive area near stimulation locations
  • Pregnant or breastfeeding

Trial locations and contacts

1 site in 1 country.

United States1 site
  • NYU Langone Health

    New York, New York, 10017

Other trials in United States

About this study

The purpose of this study is to establish the feasibility of a program of remotely supervised transcranial direct current stimulation (RS-tDCS) paired with language skills practice for people living with the semantic or logopenic variants of primary progressive aphasia (PPA). There are currently no established standard-of-care treatments for PPA. This study will evaluate whether RS-tDCS combined with language skills practice is a feasible study design for individuals with PPA.

Being tested
Transcranial Direct Current Stimulation (tDCS), Word-Naming Activity
Keywords
Transcranial Direct Current Stimulation (tDCS)
Medical subject headings
Aphasia, Primary Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcranial Direct Current Stimulation (tDCS)Device

    Also called Soterix Medical mini-CT Model 1601-LTE Stimulator

    tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through scalp sponge electrodes. The device is preprogrammed to ramp up to 2.0 mA (for 30 seconds), provide constant current throughout session (29 minutes), and then ramp down (for 30 seconds) at the end.

  • Word-Naming ActivityBehavioural

    During each tDCS session, the tDCS clinician will guide the participant in a word-naming exercise. Participants will be presented with photos of target items and prompted to verbally produce the names of the pictures.

Study groups in NCT05615922
Study groupRoleWhat they receive
Remotely Supervised tDCS and Word-Naming PracticeExperimentalAt each session, the tDCS device will deliver 2.0 mA electric current for 30 minutes over the left frontotemporal lobe with focus on the inferior frontal gyrus (IFG). Participants will receive 20 intervention sessions over the course of the interventional period (4 weeks) on weekdays (Monday-Friday). During the stimulation period, participants will engage in a picture-naming exercise as guided by the study tDCS clinicians.
Receives: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Word-Naming Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Complete 16 Out of 20 Study Visits

    Measure of feasibility.

    Measured: Week 4

Secondary outcomes (9)
  1. Number of Trained Language Probes at Treatment End

    At baseline participants were shown photos of common items and assessed for spontaneous naming of each item. Thirty items were then selected for participants to be trained on, and 30 items served as the control word naming list. At study end, participants were assessed on their ability to spontaneously name the target words without the need for cueing.

    Measured: Week 4

  2. Number of Untrained Language Probes at Treatment End

    At baseline participants were shown photos of common items and assessed for spontaneous naming of each item. Thirty items were then selected for participants to be trained on, and 30 items served as the control word naming list. At study end, participants were assessed on their ability to spontaneously name the target words without the need for cueing.

    Measured: Week 4

  3. Change in Aphasia Communication Outcome Measure (ACOM) Score

    Measurement of patient-reported communicative functioning in aphasia. Scores are presented as T-Scores that range from 0 to 100 with 50 representing the mean, with a standard deviation of ±10 indicating greater/less than average; higher T-scores indicate greater functional communication skills.

    Measured: Baseline, Month 6

  4. Change in Stroke and Aphasia Quality of Life-39 Item (SAQOL-39) Score

    39-item assessment of quality of life among individuals with aphasia. Items are ranked on a Likert scale ranging from 1 (Couldn't do it at all) to 5 (No trouble at all). The total score is the average score of all items and ranges from 1 to 5; higher scores indicate greater quality of life.

    Measured: Baseline, Month 6

  5. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities Score

    35-item measurement of the perceived ability to perform one's usual social roles and activities. Each item is rated on a Likert scale ranging from 5 (never) to 1 (always). The raw score is the sum of responses and is converted to a T-score that has a population mean score of 50 with a standard deviation of 10; higher scores indicate greater ability to perform social roles and activities.

    Measured: Baseline, Month 6

  6. Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health Score

    10-item measurement of symptoms, functioning, and healthcare-related quality of life. The raw score is the sum of responses and is converted to a T-score that has a population mean score of 50 with a standard deviation of 10; higher scores indicate better QOL.

    Measured: Baseline, Month 6

  7. Change in Quick Aphasia Battery (QAB) Score

    Assessment of language function. Includes eight subtests, each of which comprise sets of items that probe different language domains, vary in difficulty, and are scored with a graded system to maximize the informativeness of each item. The total scores range from 0 to 10, where:

    • 0.00-4.99 = Severe Aphasia
    • 5.00-7.49 = Moderate Aphasia
    • 7.50-8.89 = Mild Aphasia
    • 8.90-10.00 = No Aphasia

    Measured: Baseline, Month 6

  8. Change in Boston Naming Test (BNT)-Short Form Score

    Measures confrontational word retrieval in individuals with aphasia or other language disturbance. Consists of 15 line-drawn pictures presented in order of difficulty from "easiest" (e.g., "house") to "most difficult" (e.g., "palette"). Participants have 20 seconds to name each item correctly with a cueing hierarchy. The total score is the sum of correct responses and ranges from 0 to 15; higher scores indicate greater confrontational word retrieval abilities.

    Measured: Baseline, Month 6

  9. Change in Controlled Oral Word Association Test (COWAT) Score

    The COWAT is verbal fluency test that measures spontaneous production of words belonging to the same category or beginning with some designated letter. The participants' task is to produce as many words as possible that begin with the given letter (F, A, or S) within a 1-minute time period. The total score is the total number of acceptable words produced for all three letters. The lowest possible score is zero, meaning no words could be produced. There is no limit to the higher end of the scale given that participants can produce as many words as possible for each of the three letters. Higher scores indicate greater word retrieval and better cognitive function.

    Measured: Baseline, Month 6

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Nov 2022
  2. Study start24 Dec 2022
  3. Primary completion14 Aug 2023
  4. Study completion14 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05615922
Sponsor's protocol ID
22-01155
Status last verified
Sep 2024
First submitted
3 Nov 2022
Last updated
19 Sep 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to: \[leigh.charvet@nyulangone.org\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Transcranial Direct Current Stimulation (tDCS) and Word-Naming Activity in people with Primary Progressive Aphasia, run by NYU Langone Health at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Complete 16 Out of 20 Study Visits (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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