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

Primary Purpose

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

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
High definition transcranial alternating current stimulation
sham high definition transcranial alternating current stimulation
Sponsored by
Anhui Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Transcranial Alternating Current Stimulation focused on measuring Transcranial Alternating Current Stimulation, Functional Magnetic Resonance Imaging, Post-stroke Aphasia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Anhui Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

real stimulation

sham stimulation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

comprehension function
the change of comprehension dysfunction will be assessed by Token. Token is composed of six parts. Token scale scores range from 0 to 36 points. Lower scores indicate more severe comprehension dysfunction.
MMSE(Mini Mental State Examination)
The full name of MMSE is mini-mental state examination, and the scale consists of 30 subject, include the following seven aspects: time orientation, place orientation,immediate memory,attention and calculation,delay memory,language, visual space.One point is awarded for each question correctly answered during MMSE evaluation. If subject give the wrong answer or don't know answe he/she awarded 0 score, scope of scale score of 0 to 30 points. The higher the score, the better.

Full Information

First Posted
July 26, 2022
Last Updated
August 15, 2022
Sponsor
Anhui Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05502822
Brief Title
High Definition Transcranial Alternating Current Stimulation (HD-tACS) for Post-stroke Aphasia
Official Title
High Definition Transcranial Alternating Current Stimulation (HD-tACS) for Post-stroke Aphasia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 18, 2021 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Anhui Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transcranial Alternating Current Stimulation, Post-stroke Aphasia, Functional Magnetic Resonance Imaging
Keywords
Transcranial Alternating Current Stimulation, Functional Magnetic Resonance Imaging, Post-stroke Aphasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
real stimulation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
sham stimulation
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
High definition transcranial alternating current stimulation
Intervention Description
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
Intervention Name(s)
sham high definition transcranial alternating current stimulation
Intervention Description
. 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.
Primary Outcome Measure Information:
Title
language function
Description
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.
Time Frame
baseline and immediately after intervention
Title
resting-state functional connectivity
Description
the change of resting-state functional connectivity strength between stimulated target and the whole brain areas will be measured by functional MRI.
Time Frame
baseline and immediately after intervention
Secondary Outcome Measure Information:
Title
comprehension function
Description
the change of comprehension dysfunction will be assessed by Token. Token is composed of six parts. Token scale scores range from 0 to 36 points. Lower scores indicate more severe comprehension dysfunction.
Time Frame
baseline and immediately after intervention
Title
MMSE(Mini Mental State Examination)
Description
The full name of MMSE is mini-mental state examination, and the scale consists of 30 subject, include the following seven aspects: time orientation, place orientation,immediate memory,attention and calculation,delay memory,language, visual space.One point is awarded for each question correctly answered during MMSE evaluation. If subject give the wrong answer or don't know answe he/she awarded 0 score, scope of scale score of 0 to 30 points. The higher the score, the better.
Time Frame
baseline and immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kai Wang, PhD
Phone
+86-0551-62923704
Email
wangkai1964@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tongjian Bai
Phone
+8615256972606
Email
baiyunong1990@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaohui Xie
Organizational Affiliation
Anhui Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Anhui Medical University
City
Hefei
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tongjian Bai
Phone
+8615256972606
Email
baiyunong1990@163.com
First Name & Middle Initial & Last Name & Degree
Xiaohui Xie
Phone
17333257003
Email
xiexiaohui0318@126.com
First Name & Middle Initial & Last Name & Degree
Mengdan Zhang

12. IPD Sharing Statement

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

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