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

Primary Progressive Aphasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05615922
• Other study ID #: 22-01155
• Status: Completed
• Phase: Phase 2
• Start date: December 24, 2022
• Est. completion date: August 14, 2023

Study information

• Verified date: December 2023
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Aphasia
• Aphasia, Primary Progressive
• Frontotemporal Dementia
• Pick Disease of the Brain
• Primary Progressive Aphasia

Intervention

Device:
• 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.

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants who Complete 16 out of 20 Study Visits	Measure of feasibility.	Week 4
Secondary	Number of Trained Language Probes at Treatment End		Week 4
Secondary	Number of Untrained Language Probes at Treatment End		Week 4
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; higher T-scores indicate greater functional communication skills.	Baseline, Month 6
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.	Baseline, Month 6
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.	Baseline, Month 6
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.	Baseline, Month 6
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	Baseline, Month 6
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.	Baseline, Month 6
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. Higher scores indicate greater verbal fluency.	Baseline, Month 6