Back to resultsRemotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA)
Primary Purpose
Primary Progressive Aphasia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Word-Naming Activity
Sponsored by
About this trial
This is an interventional treatment trial for Primary Progressive Aphasia focused on measuring Transcranial Direct Current Stimulation (tDCS)
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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
Sites / Locations
- NYU Langone Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Remotely Supervised tDCS and Word-Naming Practice
Arm Description
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.
Outcomes
Primary Outcome Measures
Percentage of Participants who Complete 16 out of 20 Study Visits
Measure of feasibility.
Secondary Outcome Measures
Number of Trained Language Probes at Treatment End
Number of Untrained Language Probes at Treatment End
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.
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.
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.
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.
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
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.
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.
Full Information
NCT ID
NCT05615922
First Posted
November 3, 2022
Last Updated
September 29, 2023
Sponsor
NYU Langone Health
1. Study Identification
Unique Protocol Identification Number
NCT05615922
Brief Title
Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA)
Official Title
Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA)
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
August 18, 2023 (Actual)
Study Completion Date
August 18, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Progressive Aphasia
Keywords
Transcranial Direct Current Stimulation (tDCS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Remotely Supervised tDCS and Word-Naming Practice
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
Soterix Medical mini-CT Model 1601-LTE Stimulator
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Word-Naming Activity
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percentage of Participants who Complete 16 out of 20 Study Visits
Description
Measure of feasibility.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Number of Trained Language Probes at Treatment End
Time Frame
Week 4
Title
Number of Untrained Language Probes at Treatment End
Time Frame
Week 4
Title
Change in Aphasia Communication Outcome Measure (ACOM) Score
Description
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.
Time Frame
Baseline, Month 6
Title
Change in Stroke and Aphasia Quality of Life-39 Item (SAQOL-39) Score
Description
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
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Social Roles and Activities Score
Description
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
Title
Change in Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health Score
Description
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
Title
Change in Quick Aphasia Battery (QAB) Score
Description
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
Title
Change in Boston Naming Test (BNT)-Short form Score
Description
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
Title
Change in Controlled Oral Word Association Test (COWAT) Score
Description
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.
Time Frame
Baseline, Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leigh Charvet, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
Remotely Supervised Transcranial Direct Current Stimulation (tDCS) for Primary Progressive Aphasia (PPA)
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