Intervention Effect of Transcranial Alternating Current Stimulation(tACS) on Anxiety Disorder

NCT ID: NCT06026826

Last Updated: 2023-10-17

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To investigate the intervention effect of transcranial alternating current stimulation(tACS) on anxiety symptoms and somatic symptoms in patients with anxiety disorder and its underlying neural mechanism by MRI.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Forty patients with anxiety disorder diagnosed by DSM-5 were recruited from the second affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving tACS. After meeting the inclusion criteria and obtaining informed consent, each participant will complete the clinical evaluation, functional magnetic resonance imaging (fMRI) and 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 "active" or "sham" treatment protocol. The anode was placed over AF3 with return electrodes placed at the contralateral mastoid process. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as 8 Hz. Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

Before and after the tACS treatment, the patients had receiving a battery measure of neuropsychological tests and Magnetic resonance imaging scan in multimodalities. Neuropsychological assessment included HAMD, HAMA, PHQ15, ISI, ASI, SAS, RRS, IUS. Multimodal fMRI includes 3D-T1, rs-fMRI and DTI.

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.They were instructed to focus their answers on the past week. Afterwards, they were unblinded by the study coordinator.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Transcranial Alternating Current Stimulation Anxiety Disorder Magnetic Resonance Imaging

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

real stimulation

Participants will receive active tACS twice daily for one week. The anode was placed over AF3 with return electrodes placed at the contralateral mastoid process. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes per session, twice daily over 7 consecutive days, and the stimulus frequency was set as 8 Hz.

Group Type ACTIVE_COMPARATOR

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

Participants will receive sham tACS twice daily for one week. Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

Group Type SHAM_COMPARATOR

sham transcranial alternating current stimulation

Intervention Type DEVICE

Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 transcranial alternating current stimulation

Sham tACS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for anxiety, and HAMA\>14, PHQ-15\>5.

the age ranged from 18 to 60 years old, and the length of education was more than 5 years.

the visual acuity or corrected visual acuity is normal, right-handed, can cooperate with the completion of various experimental tests.

Exclusion Criteria

* accompanied by severe somatic diseases, such as severe heart, liver, renal insufficiency and so on.

accompanied by other neurological diseases, such as stroke, epilepsy and so on. pregnant and lactating women. accompanied by other mental disorders, such as drug abuse, schizophrenia, schizophrenic affective disorder, hysteria, autism and so on.

patients with MRI taboos or factors affecting imaging quality, such as cardiac pacemaker, cochlear implant, cardio-cerebrovascular metal stent, metal denture, etc.

those who could not cooperate with those who completed the relevant experiments, such as patients with depressive stupor, claustrophobia and so on.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Anhui Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

WANG KAI

Director of medical psychological department, Anhui Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Anhui Medical University

Hefei, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Wang Kai, PhD

Role: CONTACT

+86-0551-62923704

Tongjian Bai

Role: CONTACT

+8615256972606

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Tongjian Bai

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AHMU-tACS-anxiety

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.