High Definition Transcranial Alternating Current Stimulation (HD-tACS) for Post-stroke Aphasia
NCT ID: NCT05502822
Last Updated: 2022-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2021-03-18
2023-12-30
Brief Summary
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Detailed Description
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40 patients with language disorder diagnosed by the Aphasia Battery of Chinese (ABC) were recruited from the first affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving HD-tACS. After meeting the inclusion criteria and obtaining informed consent, each participant will complete the clinical evaluation, functional magnetic resonance imaging (fMRI) and HD-tACS treatment conducted by trained researchers at the Neuropsychological Synergetic Innovation Center of Anhui Medical University.
All the participants were randomized (1:1) to receive "real" or "sham" treatment protocol. Stimulation electrodes were arranged in a 4 × 1 ring configuration at F1, F2, C1 ,C2 and FCz, with the central one delivering an alternating current 2 mA and the surrounding 4 electrodes delivering one-fourth of the central electrode's current in the opposite polarity. The average peak-to-peak stimulation intensity across participants was 2 mA for the 6-Hz tACS. In the sham condition, 6-Hz tACS was delivered only during the ramp-up and ramp-down periods (30 s); no current was delivered during the 30-minute intervention. The tACS stimulation lasted 30 minutes, a duration that is common in cognitive neuroscience research. During the tACS, participants sat comfortably in front of a screen, training the speech and comprehension functions to follow a speech therapist.
Before and after the HD-tACS treatment, the patients had receiving a battery measure of neuropsychological tests and Magnetic resonance imaging scan in multimodalities. Neuropsychological assessment included ABC, VFT, Token, MMSE, MoCA, HAMD, HAMA, ADL. Multimodal fMRI includes 3D-T1, rs-fMRI, DTI and ASL.
Neuropsychological evaluation and magnetic resonance imaging data were obtained again 24 hours after the last treatment. The symptoms of the patients were followed up one month after the end of treatment.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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real stimulation
Stimulation electrodes were arranged in a 4 × 1 ring configuration at F1, F2, C1 ,C2 and FCz, with the central one delivering an alternating current 2 mA and the surrounding 4 electrodes delivering one-fourth of the central electrode's current in the opposite polarity. The average peak-to-peak stimulation intensity across participants was 2 mA for the 6-Hz tACS. Participants will receive real tACS once daily for two weeks.
High definition transcranial alternating current stimulation
tACS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.
sham stimulation
In the sham condition, 6-Hz tACS was delivered only during the ramp-up and ramp-down periods (30 s); no current was delivered during the 30-minute intervention. Participants will receive sham tDCS once daily for two weeks.
sham high definition transcranial alternating current stimulation
. In the sham condition, 6-Hz tACS was delivered only during the ramp-up and ramp-down periods (30 s); no current was delivered during the 30-minute intervention.
Interventions
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High definition transcranial alternating current stimulation
tACS is described as a non-invasive form of brain stimulation that uses a low-intensity, alternating current applied directly to the head through scalp electrodes.
sham high definition transcranial alternating current stimulation
. In the sham condition, 6-Hz tACS was delivered only during the ramp-up and ramp-down periods (30 s); no current was delivered during the 30-minute intervention.
Eligibility Criteria
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Inclusion Criteria
* 18-75 years old.
* native Chinese speaker.
* right-handed.
* post onset of stroke ≥6months.
Exclusion Criteria
* severe dysarthria.
* a history of head injury or surgery.
* alcohol or substance abuse.
* cerebral tumor or abscess.
18 Years
75 Years
ALL
No
Sponsors
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Anhui Medical University
OTHER
Responsible Party
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WANG KAI
Director of medical psychological department, Anhui Medical University
Principal Investigators
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Xiaohui Xie
Role: STUDY_CHAIR
Anhui Medical University
Locations
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Anhui Medical University
Hefei, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AHMU-TES-Aphaisa
Identifier Type: -
Identifier Source: org_study_id
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