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

Functional Magnetic Resonance Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05502822
• Other study ID #: AHMU-TES-Aphaisa
• Status: Recruiting
• Phase: N/A
• Start date: March 18, 2021
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2022
• Source: Anhui Medical University
• Contact: Kai Wang, PhD
• Phone: +86-0551-62923704
• Email: wangkai1964[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Anhui Medical University	Hefei

Sponsors (1)

Lead Sponsor	Collaborator
Anhui Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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.	baseline and immediately after intervention
Secondary	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.	baseline and immediately after intervention