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.
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
- Type of treatment
- Medical device, Lifestyle or therapy programme
- 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.
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.
- Conditions
- Primary Progressive Aphasia
- 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 group | Role | What they receive |
|---|---|---|
| Remotely Supervised tDCS and Word-Naming Practice | Experimental | At 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.
Percentage of Participants Who Complete 16 Out of 20 Study Visits
Measure of feasibility.
Measured: Week 4
Secondary outcomes (9)
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
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
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
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
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
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
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
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
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.
- First posted14 Nov 2022
- Study start24 Dec 2022
- Primary completion14 Aug 2023
- Study completion14 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Primary Progressive AphasiaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, PhD, Principal investigator, NYU Langone Health
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA)
- ClinicalTrials.gov ID
- NCT05615922
- Acronym / sponsor ID
- 22-01155
- Conditions
- Primary Progressive Aphasia
- Keywords
- Transcranial Direct Current Stimulation (tDCS)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 24 Dec 2022 (actual)
- Primary completion
- 14 Aug 2023 (actual)
- Study completion
- 14 Aug 2023 (actual)
- First posted
- 14 Nov 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Remotely Supervised tDCS and Word-Naming Practice | Experimental | Device: Transcranial Direct Current Stimulation (tDCS), Behavioral: Word-Naming ActivityAt 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. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Direct Current Stimulation (tDCS)Also: Soterix Medical mini-CT Model 1601-LTE StimulatortDCS 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. | Device | Remotely Supervised tDCS and Word-Naming Practice |
| Word-Naming ActivityDuring 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. | Behavioural | Remotely Supervised tDCS and Word-Naming Practice |
Primary outcome
Percentage of Participants Who Complete 16 Out of 20 Study Visits
Time frame: Week 4
Measure of feasibility.
9 secondary outcomes
Number of Trained Language Probes at Treatment End
Time frame: Week 4
Number of Untrained Language Probes at Treatment End
Time frame: Week 4
Change in Aphasia Communication Outcome Measure (ACOM) Score
Time frame: Baseline, Month 6
Change in Stroke and Aphasia Quality of Life-39 Item (SAQOL-39) Score
Time frame: Baseline, Month 6
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities Score
Time frame: Baseline, Month 6
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health Score
Time frame: Baseline, Month 6
Change in Quick Aphasia Battery (QAB) Score
Time frame: Baseline, Month 6
Change in Boston Naming Test (BNT)-Short Form Score
Time frame: Baseline, Month 6
Change in Controlled Oral Word Association Test (COWAT) Score
Time frame: Baseline, Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leigh Charvet, PhD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
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.