NCT05502822

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 18, 2021

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 16, 2022

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

August 16, 2022

Status Verified

August 1, 2022

Enrollment Period

2.8 years

First QC Date

July 26, 2022

Last Update Submit

August 15, 2022

Conditions

Transcranial Alternating Current StimulationPost-stroke AphasiaFunctional Magnetic Resonance Imaging

Keywords

Transcranial Alternating Current StimulationFunctional Magnetic Resonance ImagingPost-stroke Aphasia

Outcome Measures

Primary Outcomes (2)

  • language function

    Language deficit was assessed by the same professional language therapist using the Aphasia Battery of Chinese (ABC). The multidimensional test contains four subtypes, including spontaneous speech (semi-standardized interview, assessment of the fluency, and information of speech; total score 20 points), auditory comprehension (yes or no question, auditory picture matching task, and verbal instruction; total score 230 points), repetition (words and sentences; total score 100 points), and naming (simple objects, colors, pictures, and situations; total score 80 points). The combined score is used to calculate an aphasia quotient (AQ) reflecting the overall severity of language impairment. Patients with AQ below 93.8 points were considered as aphasic.

    baseline and immediately after intervention

  • resting-state functional connectivity

    the change of resting-state functional connectivity strength between stimulated target and the whole brain areas will be measured by functional MRI.

    baseline and immediately after intervention

Secondary Outcomes (2)

  • comprehension function

    baseline and immediately after intervention

  • MMSE(Mini Mental State Examination)

    baseline and immediately after intervention

Study Arms (2)

real stimulation

ACTIVE COMPARATOR

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.

Device: High definition transcranial alternating current stimulation

sham stimulation

SHAM COMPARATOR

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.

Device: sham high definition transcranial alternating current stimulation

Interventions

High definition transcranial alternating current stimulationDEVICE

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.

real stimulation
sham high definition transcranial alternating current stimulationDEVICE

. 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.

sham stimulation

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • mental illness .
  • severe dysarthria.
  • a history of head injury or surgery.
  • alcohol or substance abuse.
  • cerebral tumor or abscess.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Anhui Medical University

Hefei, China

RECRUITING

Study Officials

  • Xiaohui Xie

    Anhui Medical University

    STUDY CHAIR

Central Study Contacts

Kai Wang, PhD

CONTACT

+86-0551-62923704wangkai1964@126.com

Tongjian Bai

CONTACT

+8615256972606baiyunong1990@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of medical psychological department, Anhui Medical University

Study Record Dates

First Submitted

July 26, 2022

First Posted

August 16, 2022

Study Start

March 18, 2021

Primary Completion

December 30, 2023

Study Completion

December 30, 2023

Last Updated

August 16, 2022

Record last verified: 2022-08

Locations

CN(1)