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

NCT05615922 | Completed Phase 2 Results FDA Device

• 1 other identifier: 22-01155
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Progressive Aphasia

Keywords

Transcranial Direct Current Stimulation (tDCS)

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Complete 16 Out of 20 Study Visits

  Measure of feasibility.

  Week 4

Secondary Outcomes (9)

• Number of Trained Language Probes at Treatment End

  Week 4

• Number of Untrained Language Probes at Treatment End

  Week 4

• Change in Aphasia Communication Outcome Measure (ACOM) Score

  Baseline, Month 6

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

  Baseline, Month 6

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

  Baseline, Month 6

Study Arms (1)

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.

Device: Transcranial Direct Current Stimulation (tDCS); Behavioral: Word-Naming Activity

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Also known as: Soterix Medical mini-CT Model 1601-LTE Stimulator

Remotely Supervised tDCS and Word-Naming Practice

Word-Naming Activity BEHAVIORAL

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.

Remotely Supervised tDCS and Word-Naming Practice

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Aphasia, Primary Progressive

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aphasia; Speech Disorders; Language Disorders; Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Leigh Charvet, PhD
• Organization: NYU Langone Health

Leigh.Charvet@nyulangone.org

929-455-5141

Study Officials

• Leigh Charvet, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 14, 2022
• Study Start: December 24, 2022
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data upon reasonable request. Requests should be directed to leigh.charvet@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)