Skip to content

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

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05615922
Enrollment
11
Registered
2022-11-14
Start date
2022-12-24
Completion date
2023-08-14
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Progressive Aphasia

Keywords

Transcranial Direct Current Stimulation (tDCS)

Brief 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). 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.

Interventions

DEVICETranscranial Direct Current Stimulation (tDCS)

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.

BEHAVIORALWord-Naming Activity

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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
45 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

1. Primary progressive aphasia diagnosis (logopenic or semantic variant) 2. 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. 3. WAIS-IV Matrix Reasoning T score \< 20, serving as an index of current general cognitive functioning to exclude those with severe cognitive impairment 4. Stable and continuous access to internet service, email (WiFi hotspot to be provided if needed) 5. Fluent in English language (due to outcomes validated in English versions only)

Exclusion criteria

1. Disorder other than PPA known to cause language dysfunction 2. Diagnosis of nonfluent/agrammatic subtype of primary progressive aphasia 3. History of traumatic brain injury 4. Uncontrolled seizure disorder and/or recent (\<5 years) history of seizure 5. Metal implants in the head or neck 6. Any skin disorder or skin sensitive area near stimulation locations 7. Pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Participants Who Complete 16 Out of 20 Study VisitsWeek 4Measure of feasibility.

Secondary

MeasureTime frameDescription
Number of Untrained Language Probes at Treatment EndWeek 4At 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.
Change in Aphasia Communication Outcome Measure (ACOM) ScoreBaseline, Month 6Measurement 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.
Change in Stroke and Aphasia Quality of Life-39 Item (SAQOL-39) ScoreBaseline, Month 639-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.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities ScoreBaseline, Month 635-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.
Number of Trained Language Probes at Treatment EndWeek 4At 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.
Change in Quick Aphasia Battery (QAB) ScoreBaseline, Month 6Assessment 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
Change in Boston Naming Test (BNT)-Short Form ScoreBaseline, Month 6Measures 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.
Change in Controlled Oral Word Association Test (COWAT) ScoreBaseline, Month 6The 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.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health ScoreBaseline, Month 610-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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Remotely Supervised tDCS and Word-Naming Practice
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. Transcranial Direct Current Stimulation (tDCS): 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 Activity: 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.
10
Total10

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyLost to Follow-up1

Baseline characteristics

CharacteristicRemotely Supervised tDCS and Word-Naming Practice
Age, Continuous70 years
STANDARD_DEVIATION 6.9
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
10 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
10 Participants
Region of Enrollment
United States
10 participants
Sex: Female, Male
Female
4 Participants
Sex: Female, Male
Male
6 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 10
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

Percentage of Participants Who Complete 16 Out of 20 Study Visits

Measure of feasibility.

Time frame: Week 4

ArmMeasureValue (NUMBER)
Remotely Supervised tDCS and Word-Naming PracticePercentage of Participants Who Complete 16 Out of 20 Study Visits100 percentage of participants
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)Dispersion
Remotely Supervised tDCS and Word-Naming PracticeChange in Aphasia Communication Outcome Measure (ACOM) Score0.74 T-scoreStandard Deviation 0.77
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)Dispersion
Remotely Supervised tDCS and Word-Naming PracticeChange in Boston Naming Test (BNT)-Short Form Score1.6 score on a scaleStandard Deviation 0.37
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)Dispersion
Remotely Supervised tDCS and Word-Naming PracticeChange in Controlled Oral Word Association Test (COWAT) Score1.4 Correct wordsStandard Deviation 2.23
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)Dispersion
Remotely Supervised tDCS and Word-Naming PracticeChange in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health Score0.87 T-scoreStandard Deviation 0.89
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)Dispersion
Remotely Supervised tDCS and Word-Naming PracticeChange in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities Score-1.2 T-scoreStandard Deviation 3.48
Secondary

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

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)Dispersion
Remotely Supervised tDCS and Word-Naming PracticeChange in Quick Aphasia Battery (QAB) Score0.14 score on a scaleStandard Deviation 0.31
Secondary

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.

Time frame: Baseline, Month 6

ArmMeasureValue (MEAN)Dispersion
Remotely Supervised tDCS and Word-Naming PracticeChange in Stroke and Aphasia Quality of Life-39 Item (SAQOL-39) Score-0.07 score on a scaleStandard Deviation 0.2
Secondary

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.

Time frame: Week 4

ArmMeasureValue (MEAN)Dispersion
Remotely Supervised tDCS and Word-Naming PracticeNumber of Trained Language Probes at Treatment End25.1 Number of Trained Language ProbesStandard Deviation 4.33
Secondary

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.

Time frame: Week 4

ArmMeasureValue (MEAN)Dispersion
Remotely Supervised tDCS and Word-Naming PracticeNumber of Untrained Language Probes at Treatment End20.2 Number of Untrained Language ProbesStandard Deviation 7.07

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026