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

Phase 2

Completed

• Conditions: Primary Progressive Aphasia
• Interventions: Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Word-Naming Activity

• Registration Number: NCT05615922
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-11-03
• Study First Submitted QC: 2022-11-08
• Study First Posted: 2022-11-14
• Study Start: 2022-12-24
• Primary Completion: 2023-08-14
• Study Completion: 2023-08-14
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-15
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remotely Supervised tDCS and Word-Naming Practice	Transcranial Direct Current Stimulation (tDCS)	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.
Remotely Supervised tDCS and Word-Naming Practice	Word-Naming Activity	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.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Who Complete 16 Out of 20 Study Visits	Week 4	Measure of feasibility.

Secondary Outcome Measures

Name	Time	Method
Number of Trained Language Probes at Treatment End	Week 4	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.
Number of Untrained Language Probes at Treatment End	Week 4	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.
Change in Aphasia Communication Outcome Measure (ACOM) Score	Baseline, Month 6	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.
Change in Stroke and Aphasia Quality of Life-39 Item (SAQOL-39) Score	Baseline, Month 6	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.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities Score	Baseline, Month 6	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.
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health Score	Baseline, Month 6	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.
Change in Quick Aphasia Battery (QAB) Score	Baseline, Month 6	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
Change in Boston Naming Test (BNT)-Short Form Score	Baseline, Month 6	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.
Change in Controlled Oral Word Association Test (COWAT) Score	Baseline, Month 6	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.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States