High Definition Transcranial Alternating Current Stimulation (HD-tACS) for Post-stroke Aphasia

NCT ID: NCT05502822

Last Updated: 2022-08-16

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-18

Study Completion Date

2023-12-30

Brief Summary

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To investigate the intervention effect of high definition transcranial alternating current stimulation(HD-tACS) in chronic post-stroke aphasia and its underlying neural mechanism by MRI.

Detailed Description

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Aphasia is one of the most frequent cognitive deficits in poststroke survivor. More than 20% of stroke patients suffered from language impairment. The recovery of language dysfunction after stroke is highly variable. Some patients recover spontaneously in the early phases of stroke, but about two thirds of patients never fully restore language ability. The purpose of this study was to explore the intervention effect of high definition transcranial alternating current stimulation in chronic post-stroke aphasia.

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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Transcranial Alternating Current Stimulation Post-stroke Aphasia Functional Magnetic Resonance Imaging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

High definition transcranial alternating current stimulation

Intervention Type DEVICE

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.

Group Type SHAM_COMPARATOR

sham high definition transcranial alternating current stimulation

Intervention Type DEVICE

. 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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* aphasia diagnosed by the ABC.
* 18-75 years old.
* native Chinese speaker.
* right-handed.
* post onset of stroke ≥6months.

Exclusion Criteria

* mental illness .
* severe dysarthria.
* a history of head injury or surgery.
* alcohol or substance abuse.
* cerebral tumor or abscess.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

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WANG KAI

Director of medical psychological department, Anhui Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaohui Xie

Role: STUDY_CHAIR

Anhui Medical University

Locations

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Anhui Medical University

Hefei, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Kai Wang, PhD

Role: CONTACT

+86-0551-62923704

Tongjian Bai

Role: CONTACT

+8615256972606

Facility Contacts

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Tongjian Bai

Role: primary

+8615256972606

Xiaohui Xie

Role: backup

17333257003

Other Identifiers

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AHMU-TES-Aphaisa

Identifier Type: -

Identifier Source: org_study_id

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