AphasiaNCT03272906
Clinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia Therapy
A study testing Anodal transcranial direct current stimulation and Speech-language therapy in people with Aphasia and Stroke, run by Louisiana State University and A&M College at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- What is being tested?
- Anodal transcranial direct current stimulation and Speech-language therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2017to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Single, unilateral stroke resulting in aphasia
- Competency to provide written informed consent
- Ability to participate in standard aphasia therapy
Who cannot join
- 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.).
Trial locations and contacts
1 site in 1 country.
United States1 site
Louisiana State University
Baton Rouge, Louisiana, 70803
About this study
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.
Read the 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.
- Being tested
- Anodal transcranial direct current stimulation, Sham transcranial direct current stimulation, Speech-language therapy
- Keywords
- aphasia, stroke, tDCS, language, stimulation, brain, speech therapy
- Medical subject headings
- Aphasia, Stroke, Language, Communication Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anodal transcranial direct current stimulationDevice
Also called (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. A-tDCS stimulation will be active only in the first 20 minutes of the 60-minute treatment session.
Sham transcranial direct current stimulationDevice
Also called Sham
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.
Speech-language therapyBehavioural
Also called SLT
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.
| Study group | Role | What they receive |
|---|---|---|
| A-tDCS & speech-language therapy | Experimental | 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. Receives: Device: Anodal transcranial direct current stimulation; Behavioral: Speech-language therapy |
| Sham-tDCS & speech-language therapy | Sham comparator | 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. Receives: Device: Sham transcranial direct current stimulation; Behavioral: Speech-language therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Following 8 weeks of speech-language therapy
Secondary outcomes (3)
Western Aphasia Battery-Revised (WAB-R)
Change in performance on Part 1 of WAB-R (Aphasia Quotient)
Measured: Following 8 weeks of speech-language therapy
Communication Activities of Daily Living-2 (CADL-2)
Change in performance on CADL-2
Measured: Following 8 weeks of speech-language therapy
Philadelphia Naming Test - Short Form (PNT)
Change in performance on PNT
Measured: Following 8 weeks of speech-language therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study start31 Aug 2017
- Primary completion30 Jun 2021
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AphasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisiana State University and A&M College
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, E. Susan Duncan, Louisiana State University and A&M College
- Investigators
- E. Susan Duncan, PhD, CCC-SLP, Principal investigator, Lousiana State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272906
- Sponsor's protocol ID
- LEQSF(2017-20)-RD-A-03
- Status last verified
- Mar 2024
- First submitted
- 2 Sep 2017
- Last updated
- 21 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility of Transcranial Direct Current Stimulation [tDCS] With Standard Aphasia Therapy
- ClinicalTrials.gov ID
- NCT03272906
- Acronym / sponsor ID
- LEQSF(2017-20)-RD-A-03
- Keywords
- aphasia, stroke, tDCS, language, stimulation, brain, speech therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Louisiana State University and A&M CollegeUniversity, hospital or other
- Study start
- 31 Aug 2017 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 6 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-tDCS & speech-language therapy | Experimental | Device: Anodal transcranial direct current stimulation, Behavioral: Speech-language therapyAnodal 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. |
| Sham-tDCS & speech-language therapy | Sham comparator | Device: Sham transcranial direct current stimulation, Behavioral: Speech-language therapySham 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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Single, unilateral stroke resulting in aphasia
- Competency to provide written informed consent
- Ability to participate in standard aphasia therapy
Key exclusion criteria (6 listed)
- Serious psychological condition
- Serious neurological condition, other than stroke
- Serious medical condition
- Pregnancy
- History of seizures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anodal transcranial direct current stimulationAlso: (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. A-tDCS stimulation will be active only in the first 20 minutes of the 60-minute treatment session. | Device | A-tDCS & speech-language therapy |
| Sham transcranial direct current stimulationAlso: Sham2 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. | Device | Sham-tDCS & speech-language therapy |
| Speech-language therapyAlso: SLTTherapy 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. | Behavioural | A-tDCS & speech-language therapy, Sham-tDCS & speech-language therapy |
Primary outcome
Production of Correct Information Units (CIUs) in Cinderella narrative
Time frame: Following 8 weeks of speech-language therapy
Change in CIU production over treatment interval. Words are counted as CIUs if they are novel, intelligible, and appropriate in context
3 secondary outcomes
Western Aphasia Battery-Revised (WAB-R)
Time frame: Following 8 weeks of speech-language therapy
Communication Activities of Daily Living-2 (CADL-2)
Time frame: Following 8 weeks of speech-language therapy
Philadelphia Naming Test - Short Form (PNT)
Time frame: Following 8 weeks of speech-language therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
Related trials for Aphasia
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Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
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Restoring Speech With an Intracortical Neuroprosthesis for Post-Stroke Agrammatic Aphasia (BG-Aphasia-02)
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Not yet recruitingObservational study
Detecting and Predicting Post-stroke Cognitive Impairment Using the Oxford Cognitive Screen
Stroke, Ischemic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
E. Susan Duncan, PhD, CCC-SLP principal investigator
Lousiana State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anodal transcranial direct current stimulation and Speech-language therapy in people with Aphasia and Stroke, run by Louisiana State University and A&M College at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Production of Correct Information Units (CIUs) in Cinderella narrative (time frame: Following 8 weeks of speech-language therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2024.