An interventional study of Anodal transcranial direct current stimulation and Sham transcranial direct current stimulation in Aphasia and Stroke, sponsored by Louisiana State University and A&M College. Completed at 1 site in United States. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Louisiana State University and A&M College · Not applicable, Interventional, and Treatment
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.
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:
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.
338 studies on the registry are indexed under Aphasia; 95 are open to participants now.
This study's enrollment of 7 is below the median of 30 across 298 interventional studies indexed under Aphasia.
Browse Aphasia studies →Louisiana State University and A&M College is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anodal transcranial direct current stimulation (2 mA) plus speech-language therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. The electrical current will be administered over ventral inferior frontal gyrus. The stimulation will be delivered at an intensity of 2mA for a maximum of 20 minutes.
Device: Anodal transcranial direct current stimulation · Behavioral: Speech-language therapy
Sham transcranial direct current stimulation (2 mA) plus speech-language therapy for 16 sessions (20-minutes per each 60-minute treatment session) over the course of 8 weeks. Electrodes will be placed as in A-tDCS. Current will be ramped up for the first 30 seconds following which the intensity will drop to 0 mA.
Device: Sham transcranial direct current stimulation · Behavioral: Speech-language therapy
2 mA of A-tDCS stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 2 mA occurs over 30 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 60-minute treatment session.
Also known as: (A-tDCS)
2 mA of A-tDCS stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 2 mA occurs over 30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition.
Also known as: Sham
Therapy tasks will be determined by the clinician on an individualized basis and will not be affected by this research protocol. The only difference between the clinical therapy that is normally provided in the clinic and this research paradigm is the application of tDCS electrodes during therapy. Therapist is blinded to stimulation type.
Also known as: SLT
Production of Correct Information Units (CIUs) in Cinderella narrative
Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, and appropriate in context
Time frame: Following 8 weeks of speech-language therapy
Western Aphasia Battery-Revised (WAB-R)
Change in performance on Part 1 of WAB-R (Aphasia Quotient)
Time frame: Following 8 weeks of speech-language therapy
Communication Activities of Daily Living-2 (CADL-2)
Change in performance on CADL-2
Time frame: Following 8 weeks of speech-language therapy
Philadelphia Naming Test - Short Form (PNT)
Change in performance on PNT
Time frame: Following 8 weeks of speech-language therapy
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Louisiana State University and A&M College