Clinical trial NCT03272906: Clinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia Therapy
Official title: Clinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphasia
Stroke
Keywords: aphasia
stroke
tDCS
language
stimulation
brain
speech therapy
Lead sponsor: Louisiana State University and A&M College
Sponsor class: OTHER
First posted: 2017-09-06
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Study Design: This is a within-subjects crossover design. Subjects will participate in the procedures twice, once under each condition (active vs. sham stimulation). The order of conditions will be counter-balanced across subjects. Stimulation will target ventral inferior frontal gyrus (IFG) and will be paired with standard speech-language therapy. Outcome measures will be acquired at the beginning and end of a semester of standard speech-language therapy.

Detailed description: Baseline Behavioral Assessment: Medical and neurological history will be taken. Western Aphasia Battery-Revised, Communication Activities of Daily Living-2, and Philadelphia Naming Test (short form) will be administered. Narrative will be elicited (Cinderella story). Some of these procedures will be videorecorded for later transcription. Subjects will also complete a pre-tDCS safety screening questionnaire.

tDCS: Participants will undergo placement of 2 tDCS electrodes. For all subjects, the anodal electrode will be placed at the following locations (EEG 10-20 system):

(i) over the left inferior frontal gyrus (crossing point between T3-Fz and F7-Cz)

The cathodal electrode will be placed at the second site:

(ii) over right frontal pole (Fp2)

Two types of stimulation will be given, an active condition and a sham condition. In the sham condition, stimulation is ramped up over the first 30 seconds (as in the active condition), but then discontinued. This gives the physical perception of stimulation without the modulatory effects.

Stimulation will be delivered by a tDCS device with the following parameters for intensity and duration:

* Intensity: 2 mA
* Duration: 20 minutes

tDCS will be provided for the first 20 minutes of each aphasia therapy session provided at the LSU Speech-Language-Hearing Clinic. The therapy sessions last for one hour and are provided twice weekly for 8 weeks over the course of an academic semester (fall and spring).

Post-Therapy/Stimulation Assessment: Western Aphasia Battery-Revised, Communication Activities of Daily Living-2, and Philadelphia Naming Test (short form) will be administered as before therapy. Cinderella narrative will again be elicited. Some of these procedures will again be videorecorded for later transcription. A tDCS sensations survey will also be completed at the final assessment to determine the effectiveness of blinding.

Eligibility criteria: Inclusion Criteria:

* Single, unilateral stroke resulting in aphasia
* Competency to provide written informed consent
* Ability to participate in standard aphasia therapy

Exclusion Criteria:

* Serious psychological condition
* Serious neurological condition, other than stroke
* Serious medical condition
* Pregnancy
* History of seizures
* Presence of electronic or metal implants (e.g., pacemaker, vagal nerve stimulator, etc.).

Primary outcomes:
measure: Production of Correct Information Units (CIUs) in Cinderella narrative
timeFrame: Following 8 weeks of speech-language therapy
Secondary outcomes:
measure: Western Aphasia Battery-Revised (WAB-R)
timeFrame: Following 8 weeks of speech-language therapy
measure: Communication Activities of Daily Living-2 (CADL-2)
timeFrame: Following 8 weeks of speech-language therapy
measure: Philadelphia Naming Test - Short Form (PNT)
timeFrame: Following 8 weeks of speech-language therapy
Other outcomes:
Locations:
city: Baton Rouge
country: United States
facility: Louisiana State University
state: Louisiana
Study officials:
affiliation: Lousiana State University
name: E. Susan Duncan, PhD, CCC-SLP
role: PRINCIPAL_INVESTIGATOR
References: