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Treating Primary Progressive Aphasia (PPA) Using High-definition tDCS

Primary Purpose

Primary Progressive Aphasia

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
high-definition transcranial direct current stimulation
modified constraint-induced language therapy
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Progressive Aphasia focused on measuring non-invasive brain stimulation, transcranial direct current stimulation (tDCS), aphasia

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Presence of aphasia attributable to nonfluent agrammatic PPA (naPPA) or logopenic variant PPA (lvPPA)
  2. High school education (or more)
  3. Must be able to understand the nature of the study, and give informed consent
  4. Native English speaker

Exclusion Criteria:

  • Presence of additional neurological illness such as stroke or traumatic brain injury
  • Diagnosis of epilepsy or reoccurening seizures
  • Pacemaker or ICDs
  • Craniotomy or skull breech
  • Small vessel disease

Sites / Locations

  • University of PennsylvaniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

HD-tDCS+mCILT

Sham+mCILT

Arm Description

Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of HD-tDCS for 20 minutes using a montage in which a central electrode (1.5mA) is placed over the left frontotemporal area and four surrounding cathodes (.375mA each). Subjects will participate in a modified constraint-induced language therapy.

Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of sham for 20 minutes using a montage in which a central electrode is placed over the left frontotemporal area and four surrounding cathodes. Subjects will participate in a modified constraint-induced language therapy,

Outcomes

Primary Outcome Measures

Change in Western Aphasia Battery Aphasia Quotient (WAB-AQ)
The primary outcome measure will be the change in score on the WAB-AQ, a score assessing overall aphasia recovery. Scores can range from 0-100. 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild. A score of 93 or higher is considered recovered.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2019
Last Updated
October 24, 2023
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT04046991
Brief Title
Treating Primary Progressive Aphasia (PPA) Using High-definition tDCS
Official Title
Treating Primary Progressive Aphasia (PPA) and Elucidating Neurodegeneration in the Language Network Using Transcranial Direct Current Stimulation (tDCS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

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
Yes

5. Study Description

Brief Summary
This is a double-blind, sham-controlled, crossover study in which subjects with the non-fluent/agrammatic and logopenic variants of primary progressive aphasia (naPPA and lvPPA, respectively) will undergo language testing and structural and functional brain imaging before and after receiving 10 semi-consecutive daily sessions of real or sham high-definition transcranial direct current stimulation (HD-tDCS) paired with modified constraint-induced language therapy (mCILT). Language testing and brain imaging will be repeated immediately after completion of and 3 months following completion of treatment. The 3-month follow-up will be the primary endpoint. The investigators will examine changes in language performance induced by HD-tDCS + mCILT compared to sham HD-tDCS + mCILT. The investigators will also use network science to analyze brain imaging (fMRI) data to identify network properties associated with baseline PPA severity and tDCS-induced changes in performance. This study will combine knowledge gained from our behavioral, imaging, and network data in order to determine the relative degrees to which these properties predict whether persons with PPA will respond to intervention.
Detailed Description
The central framework for the project is a double-blind, sham-controlled, crossover study in which subjects with the non-fluent/agrammatic and logopenic variants of primary progressive aphasia (naPPA and lvPPA, respectively) will undergo language testing and structural and functional brain imaging before and after receiving 10 semi-consecutive daily sessions of real or sham high definition transcranial direct current stimulation (HD-tDCS) paired with modified constraint-induced language therapy (mCILT). Language testing and brain imaging will be repeated immediately after completion of and 3 months following completion of treatment. Subjects with naPPA and lvPPA will be randomized to one of two study arms: HD-tDCS+mCILT or sham stimulation+mCILT paired with pre- and post-stimulation imaging and behavioral measures. Equal numbers of subjects with naPPA and lvPPA will be randomized to the HD-tDCS + mCILT and sham + mCILT study arms. The study is double-blinded, in that neither the subject nor the study personnel administering HD-tDCS or sham stimulation will know which arm of the study the subject has been randomized into. Study coordinators will administer HD-tDCS by entering a pre-determined code that has been programmed into the device by another member of the study team. Data will be digitally audio-recorded and analyzed off-line, such that study team members performing data coding and analysis will likewise be blinded to the treatment condition of each subject. Subject participation in this protocol will occur during 27 planned visits that will span approximately 8 months. The events of the study visits are described below: VISIT 1: a Informed consent and screening b. Baseline language assessment #1 c. Baseline MRI scanning VISIT 2: Baseline language assessment #2 VISITS 3-11: HD-tDCS+mCILT OR sham stimulation+mCILT, depending on the study arm to which they had been randomized. VISIT 12: Final session of HD-tDCS+mCILT or sham stimulation+mCILT Follow-up language assessment Follow-up MRI VISIT 13: 6-Week follow-up language assessment VISIT 14: 12-week follow-up language assessment 12-week follow-up MRI **CROSSOVER** VISIT 15: Crossover baseline language assessment #2 VISITS 16-24: HD-tDCS+mCILT or sham stimulation+mCILT VISIT 25: 10th session of HD-tDCS+mCILT or sham stimulation+mCILT Follow-up language assessment Follow-up MRI VISIT 26: 6 Week follow-up language assessment: VISIT 27: 12-week follow-up language assessment 12-week follow-up MRI

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Progressive Aphasia
Keywords
non-invasive brain stimulation, transcranial direct current stimulation (tDCS), aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HD-tDCS+mCILT
Arm Type
Active Comparator
Arm Description
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of HD-tDCS for 20 minutes using a montage in which a central electrode (1.5mA) is placed over the left frontotemporal area and four surrounding cathodes (.375mA each). Subjects will participate in a modified constraint-induced language therapy.
Arm Title
Sham+mCILT
Arm Type
Sham Comparator
Arm Description
Participants will undergo 10 daily sessions (Monday-Friday, x2 weeks) of sham for 20 minutes using a montage in which a central electrode is placed over the left frontotemporal area and four surrounding cathodes. Subjects will participate in a modified constraint-induced language therapy,
Intervention Type
Device
Intervention Name(s)
high-definition transcranial direct current stimulation
Intervention Description
High definition transcranial direct current stimulation (HD-tDCS) involves the application of low-intensity current through electrodes placed on the scalp. It is believed to elicit brain effects by producing incremental shifts in the resting membrane potential of large numbers of neurons, which alters neuronal firing rates and thus modulates patterns of brain activity in potentially behaviorally-relevant ways. HD-tDCS differs from conventional transcranial direct current stimulation (tDCS) because it employed smaller electrodes configured in such a way as to deliver more focal stimulation of the brain.
Intervention Type
Behavioral
Intervention Name(s)
modified constraint-induced language therapy
Intervention Description
Modified constraint-induced language therapy (mCILT) is a behavioral language therapy that invokes use-dependent learning in communicative interactions by requiring spoken output and restricting use of alternative forms of communication, such as gestures, as a substitute for spoken output. Other key elements of CILT include massed practice of goal-directed speech and shaping of desired responses by increasing response demands as participants improve. MCILT differs from traditional constraint-induced language therapy (CILT) in three ways: 1) it will be done as an individual therapy with the examiner in the role of a communication partner; 2) treatment will be delivered in short sessions (1 hour rather than a more typical 3-4 hour session); 3) targeting nouns + semantically related verbs to generate noun + verb phrases in treatment, a modification that may be better suited to addressing syntactic structure.
Primary Outcome Measure Information:
Title
Change in Western Aphasia Battery Aphasia Quotient (WAB-AQ)
Description
The primary outcome measure will be the change in score on the WAB-AQ, a score assessing overall aphasia recovery. Scores can range from 0-100. 0-25 is very severe, 26-50 is severe, 51-75 is moderate, and 76-above is mild. A score of 93 or higher is considered recovered.
Time Frame
Baseline, 2 weeks, 6 weeks, 12 weeks, 14 weeks, 18 weeks, 24 weeks

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: Presence of aphasia attributable to nonfluent agrammatic PPA (naPPA) or logopenic variant PPA (lvPPA) High school education (or more) Must be able to understand the nature of the study, and give informed consent Native English speaker Exclusion Criteria: Presence of additional neurological illness such as stroke or traumatic brain injury Diagnosis of epilepsy or reoccurening seizures Pacemaker or ICDs Craniotomy or skull breech Small vessel disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Megan Hoffman, BS
Phone
215-573-4336
Email
megan.hoffman1@pennmedicine.upenn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Daniela Sacchetti, MS
Phone
215-573-8485
Email
danielas@pennmedicine.upenn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy H Hamilton, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Sacchetti, MS

12. IPD Sharing Statement

Learn more about this trial

Treating Primary Progressive Aphasia (PPA) Using High-definition tDCS

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