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Brain Stimulation and Aphasia Treatment (tDCS)

Primary Purpose

Aphasia

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Activa Dose II Real tDCS

Activa Dose II Sham tDCS

About this trial

This is an interventional treatment trial for Aphasia focused on measuring Aphasia, Brain, Stimulation, Communication, Stoke, Post, Phase II Clinical Trial, Treatment, tDCS, Fridriksson

Eligibility Criteria

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

Inclusion Criteria:

Patients must be willing and able to give informed consent.
Patients must be willing and able to comply with study requirements.
Patients must be between 25- and 80-years of age.
Patients must be native English speakers.
Patients must be pre-morbidly right-handed.
Patients must have sustained a one-time ischemic stroke in the left-hemisphere.
Patients must be greater than 6-months post-stroke.
Patients must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised.
Patients must be MRI-compatible (e.g., no metal implants, not claustrophobic, etc.).
Patients must achieve at least 65% accuracy on naming task during screening -

Exclusion Criteria:

History of brain surgery
Seizures during the previous 12 months
Sensitive scalp (per patient report)
Able to overtly name more than an average of 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test) during Visits 2 or 3.
Unable to overtly name at least an average of 5 out of 80 items during the pre-treatment functional magnetic resonance imaging (fMRI) sessions during Visits 2 or 3.

Sites / Locations

Medical University of South Carolina
University of South Carolina (USC)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Activa Dose II Real tDCS

Activa Dose II Sham tDCS

Arm Description

Actual delivery of electrical stimulation

Sham delivery of electrical stimulation

Outcomes

Primary Outcome Measures

The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).

The PNT includes 175 items and has a minimum score of 0 (zero items named correctly) and a maximum score of 175 (all items named correctly). The Naming 80 includes a portion of the trained treatment items (N=80) with a minimum score of 0 (zero items named correctly) and a maximum score of 80 (all items named correctly). For both scales, higher values represent better outcome. The average of two administrations of the PNT were added to the the average of two administrations of the Naming 80 for both time points. The outcome measure is the change in that value (averaged PNT + averaged Naming 80) from baseline to immediately post-treatment. Only two timepoints are used for this calculation: baseline and immediately post-treatment.

Secondary Outcome Measures

Full Information

NCT ID

NCT01686373

First Posted

September 7, 2012

Last Updated

July 31, 2019

Sponsor

University of South Carolina

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD), Medical University of South Carolina

1. Study Identification

Unique Protocol Identification Number

NCT01686373

Brief Title

Brain Stimulation and Aphasia Treatment

Acronym

tDCS

Official Title

Transcranial Direct Current Stimulation and Aphasia Treatment Outcomes

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

May 2017 (Actual)

Study Completion Date

October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of South Carolina

Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD), Medical University of South Carolina

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to assess the changes in language processing of patients with chronic, post-stroke aphasia following the application of brain stimulation. The brain stimulation the investigators administer is called transcranial direct current stimulation (tDCS). It involves passing a weak electrical current through the brain between two electrodes in the form of damp sponges. One sponge will be placed over a specified area on the damaged left hemisphere, while the other sponge will be placed on the right scalp. Computer-controlled speech-language treatment will be administered during the application of tDCS.

Detailed Description

Stroke is the leading cause of adult disability in the United States. Approximately one-third of all strokes result in acute language impairment (aphasia), with approximately one-fifth suffering from chronic aphasia. Unfortunately, the prognosis for moderate to severe chronic aphasia remains grim, as current behavioral treatment approaches usually offer only limited-to-modest benefit. Recent advancements in understanding the relationship between low current electrical brain stimulation and cortical plasticity suggest that the effect of behavioral aphasia treatment could possibly be enhanced using anodal transcranial direct current stimulation (A-tDCS). Indeed, we have shown how A-tDCS can significantly boost the effect of behavioral aphasia treatment. Based on these results as well as our other studies aimed at understanding how favorable brain plasticity correlates with positive treatment outcome in aphasia, we propose to conduct a Phase II clinical trial utilizing a futility design. Consistent with the goals of Program Announcement PAR-08-204 by the National Institute on Deafness and Other Communication Disorders (NIDCD), we plan to "evaluate whether there is sufficient evidence of short term improvement in humans to justify a phase III trial."

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aphasia

Keywords

Aphasia, Brain, Stimulation, Communication, Stoke, Post, Phase II Clinical Trial, Treatment, tDCS, Fridriksson

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Activa Dose II Real tDCS

Arm Type

Experimental

Arm Description

Actual delivery of electrical stimulation

Arm Title

Activa Dose II Sham tDCS

Arm Type

Placebo Comparator

Arm Description

Sham delivery of electrical stimulation

Intervention Type

Device

Intervention Name(s)

Activa Dose II Real tDCS

Intervention Description

20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions)

Intervention Type

Device

Intervention Name(s)

Activa Dose II Sham tDCS

Intervention Description

20 minutes of sham stimulation per treatment day (15 total sessions)

Primary Outcome Measure Information:

Title

The Philadelphia Naming Test (PNT) Plus the Naming 80 (a Portion of the Trained Items).

Description

Time Frame

Immediately post-treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients must be willing and able to give informed consent. Patients must be willing and able to comply with study requirements. Patients must be between 25- and 80-years of age. Patients must be native English speakers. Patients must be pre-morbidly right-handed. Patients must have sustained a one-time ischemic stroke in the left-hemisphere. Patients must be greater than 6-months post-stroke. Patients must have an aphasia diagnosis as confirmed by the Western Aphasia Battery-Revised. Patients must be MRI-compatible (e.g., no metal implants, not claustrophobic, etc.). Patients must achieve at least 65% accuracy on naming task during screening - Exclusion Criteria: History of brain surgery Seizures during the previous 12 months Sensitive scalp (per patient report) Able to overtly name more than an average of 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test) during Visits 2 or 3. Unable to overtly name at least an average of 5 out of 80 items during the pre-treatment functional magnetic resonance imaging (fMRI) sessions during Visits 2 or 3.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Julius Fridriksson, PhD

Organizational Affiliation

Director

Official's Role

Principal Investigator

Facility Information:

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

University of South Carolina (USC)

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29208

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

30128538

Citation

Fridriksson J, Rorden C, Elm J, Sen S, George MS, Bonilha L. Transcranial Direct Current Stimulation vs Sham Stimulation to Treat Aphasia After Stroke: A Randomized Clinical Trial. JAMA Neurol. 2018 Dec 1;75(12):1470-1476. doi: 10.1001/jamaneurol.2018.2287.

Results Reference

derived

Links:

URL

http://sph.sc.edu/comd/fridriks/

Description

University of South Carolina Aphasia Laboratory

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Brain Stimulation and Aphasia Treatment

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