Superiority Trial of Aphasia-focused Rehabilitation With tDCS Stimulation

Официальное название

Transcranial Direct Current Stimulation to Treat Aphasia: A Superiority Study

Обзор

The purpose of this study is to help us understand if adding transcranial Direct Current Stimulation (tDCS), a non-invasive brain stimulation technique, to Speech Therapy improves language recovery in people with Broca's aphasia and is more effective than Speech Therapy alone.

Подробное описание

This project is a prospective randomized controlled double-blinded clinical trial to compare auditory-visual speech therapy coupled with adjuvant active anodal tDCS (A-tDCS) versus speech therapy coupled with sham tDCS (S-tDCS). The investigators will perform an adaptive Phase II/III design, in which the first portion of the study (Phase II) will determine the optimal dose of A-tDCS (1 mA versus 2 mA) and provide a go/no-go decision for Phase III. The investigators will use a 10-10 system to determine electrode placement, with 5 x 5 cm pads, and stimulation duration will be 20 minutes. Phase III will test the definitive superiority of adjuvant A-tDCS at the optimal dose coupled with speech therapy versus speech therapy alone (S-tDCS) to improve naming among individuals with chronic Broca's aphasia.

Вмешательства

• Устройство tDCS
  The study intervention will be delivered using the Soterix 1x1 Transcranial Electrical Stimulation Clinical Trials device (Soterix Medical Inc., New York).

Первичные конечные точки

• Naming [Срок оценки: From baseline assessment to 4-weeks post treatment]

Вторичные конечные точки (7)

• Naming [Срок оценки: From baseline assessment to 1-week post treatment]
• Naming [Срок оценки: From baseline assessment to 24-weeks post treatment]
• Aphasia Severity [Срок оценки: From baseline assessment to 4-weeks post treatment]
• Functional Communication [Срок оценки: From baseline assessment to 4-weeks post treatment]
• Quality of Life [Срок оценки: From baseline assessment to 4-weeks post treatment]
• Communication Confidence [Срок оценки: From baseline assessment to 4-weeks post treatment]
• Safety [Срок оценки: From baseline assessment to 4-weeks post treatment]

Критерии участия

Критерии включения

• Be willing and able to give informed consent.
• Be willing and able to comply with study requirements.
• Be between 25 and 80 years of age.
• Have used English as the primary language for > 15 years.
• Have the diagnosis of aphasia due to a left hemisphere stroke, confirmed by study physician based on past clinical MRI scan or research scan.
• Be greater than 6 months post-stroke.
• Have Broca's aphasia diagnosed by the WAB-R (fluency score ≤ 5, auditory verbal comprehension score 4-10, repetition score 0-7.9, naming and word finding score < 9).
• Correctly name 140 or fewer items on the PNT.

Критерии исключения

• History of brain surgery except for during the treatment of the acute stroke.
• Seizures during the previous 12-months.
• Compromised skin at or near electrode sites (e.g., rash, eczema, wounds, infection).
• Correctly name more than 140 out of 175 items during the pre-treatment picture naming test (Philadelphia Naming Test).
• Western Aphasia Battery-Revised Aphasia Quotient (WAB-R AQ) score of 25 or below.
• Participants with open skull defects (e.g., greater than 1 cm) in the area underneath the anode electrode positioning or participants with metal implants or electrical stimulators.
• Participants with continuous oxygen therapy which cannot be discontinued for more than 1 hour.
• Any condition or situation that the PI determines would significantly interfere with the participant's ability to complete the study.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 3 центра

• Medical University of South Carolina — Charleston
• University of South Carolina — Columbia
• University of Utah — Salt Lake City

Публикации

• Baker JM, Rorden C, Fridriksson J. Using transcranial direct-current stimulation to treat stroke patients with aphasia. Stroke. 2010 Jun;41(6):1229-36. doi: 10.1161/STROKEAHA.109.576785. Epub 2010 Apr 15. PMID 20395612
• 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. PMID 30128538
• Fridriksson J, Basilakos A, Stark BC, Rorden C, Elm J, Gottfried M, George MS, Sen S, Bonilha L. Transcranial direct current stimulation to treat aphasia: Longitudinal analysis of a randomized controlled trial. Brain Stimul. 2019 Jan-Feb;12(1):190-191. doi: 10.1016/j.brs.2018.09.016. Epub 2018 Sep 29. No abstract available. PMID 30318184
• Wilmskoetter J, Fridriksson J, Basilakos A, Phillip Johnson L, Marebwa B, Rorden C, Warner G, Hickok G, Hillis AE, Bonilha L. Indirect White Matter Pathways Are Associated With Treated Naming Improvement in Aphasia. Neurorehabil Neural Repair. 2021 Apr;35(4):346-355. doi: 10.1177/1545968321999052. Epub 2021 Mar 10. PMID 33719732
• Bonilha L, Rorden C, Roth R, Sen S, George MS, Fridriksson J. Improved naming in patients with Broca's aphasia with tDCS. J Neurol Neurosurg Psychiatry. 2024 Feb 14;95(3):273-276. doi: 10.1136/jnnp-2023-331541. PMID 38071545

Идентификаторы

NCT: NCT07688551 · STUDY00000004 · U01DC022447

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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