Therapeutic Effect of Neuromodulation on Anxiety Disorders by High-Definition Transcranial Electrical Stimulation

January 9, 2025 updated by: National Taiwan University Hospital

High-definition transcranial electrical stimulation (HD-tES) is a non-invasive brain neuromodulation technique that applies a small electrical current to the scalp to alter neural excitability and stimulate localized brain activation. Previous clinical trials have explored the use of HD-tES for treating mental health conditions such as depression, anxiety, obsessive-compulsive disorder, and post-traumatic stress disorder. This trial aims to investigate the efficacy and safety of HD-tES in ameliorating anxiety symptoms among patients with generalized anxiety disorder (GAD), thereby validating its potential as a treatment for anxiety disorders.

Participants will be randomly assigned to one of four HD-tES treatment groups: (1) HD-tES inhibitory waveform (cDC+cTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes. (2) Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes. (3) HD-tES inhibitory waveform (cDC+cTBS) applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes. (4) Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes. Regardless of the group assignment, participants will undergo treatment sessions over a 2-week period, with five sessions per week and no more than one session per day. Each session lasts approximately 20 minutes. Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 65 years.
  • Diagnosed with Generalized Anxiety Disorder (GAD) by a psychiatrist according to DSM-5 criteria.
  • Hamilton Anxiety Rating Scale (HAM-A) score ≥ 14.
  • Hamilton Depression Rating Scale (HAM-D; 17-item version) score ≤ 17.
  • Has been consistently receiving psychological counseling and/or medication with stable types and dosages for at least 6 weeks prior to enrollment; or is deemed unsuitable for medication and/or psychological counseling; or refuses medication and/or psychological counseling.

Exclusion Criteria:

  • Received rTMS or any other form of non-invasive brain stimulation techniques within 2 weeks prior to the study and during the study period.
  • Presence of severe neurological disorders (e.g., stroke, brain tumor, epilepsy, organic brain diseases) or psychiatric disorders (e.g., schizophrenia and other psychotic disorders, bipolar disorder, obsessive-compulsive disorder, other types of anxiety disorders, substance abuse).
  • Severe or unstable physiological conditions that may affect the autonomic or central nervous system (e.g., acute gastrointestinal diseases, cardiovascular diseases, thyroid disorders).
  • History of cardiac arrhythmia.
  • Presence of implanted medical electronic devices (e.g., pacemakers).
  • Presence of metallic implants in the head or neck region.
  • Open wounds on the scalp at the site of electrode contact.
  • History of head surgery or significant head trauma that, based on physician evaluation, makes the individual unsuitable for inclusion.
  • Individuals with significant suicide risk (HAM-D Item 3 score on suicidal risk ≥ 3).
  • Presence of immune disorders (e.g., systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, inflammatory bowel diseases).
  • Individuals with abnormal or heightened sensitivity to electrical stimulation, making them unable to tolerate it.
  • Pregnancy (for female participants: must be postmenopausal or surgically sterilized. Females of childbearing potential must have a negative pregnancy test. Female participants capable of becoming pregnant and their male partners with female partners capable of becoming pregnant must agree to use effective contraception during the trial and for 4 months after the last study intervention, such as oral contraceptives, dual barrier methods, or intrauterine devices, or agree to abstain from sexual activity during this period. Non-childbearing females are defined as those who have undergone bilateral oophorectomy or are postmenopausal).
  • Taking medications that lower the seizure threshold.
  • Alcohol or substance abuse.
  • Convexity skull defects or elevated intracranial pressure.
  • Breastfeeding women.
  • Other conditions deemed unsuitable for transcranial electrical stimulation based on physician evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HD-R_cDC+cTBS & sham-L_aDC+iTBS
Device: HD-R_cDC+cTBS & sham-L_aDC+iTBS
HD-tES inhibitory waveform (cDC+cTBS) applied to the right dorsolateral prefrontal cortex (DLPFC) for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes.
Experimental: sham-R_cDC+cTBS & HD-L_aDC+iTBS
Device: sham-R_cDC+cTBS & HD-L_aDC+iTBS
Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes.
Experimental: HD-R_cDC+cTBS & HD-L_aDC+iTBS
Device: HD-R_cDC+cTBS & HD-L_aDC+iTBS
HD-tES inhibitory waveform (cDC+cTBS) applied to the right DLPFC for 10 minutes, followed by HD-tES excitatory waveform (aDC+iTBS) applied to the left DLPFC for 10 minutes.
Sham Comparator: sham-R_cDC+cTBS & sham-L_aDC+iTBS
Device: sham-R_cDC+cTBS & sham-L_aDC+iTBS
Sham inhibitory waveform (cDC+cTBS) stimulation applied to the right DLPFC for 10 minutes, followed by sham excitatory waveform (aDC+iTBS) stimulation applied to the left DLPFC for 10 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in severity of anxious symptoms as assessed by Hamilton Anxiety Rating Scale (HAM-A) and after intervention
Time Frame: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Change in state and trait anxiety as assessed by State-Trait Anxiety Inventory (STAI) after intervention
Time Frame: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in severity of depressive symptoms as assessed by Hamilton Depression Scale (HAM-D) after intervention
Time Frame: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Change in sleep quality as assessed by Pittsburgh Sleep Quality Index (PSQI) after intervention
Time Frame: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Self-rated anxiety level as assessed by Visual Analog Scale (VAS)
Time Frame: Within 3 minute after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Within 3 minute after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Heart Rate Variability (HRV) as assessed by NeXus-10MK Ⅱ
Time Frame: Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Side effects as assessed by Side Effects Questionnaire
Time Frame: Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)
Within 10 minutes after each intervention session (a total of 10 sessions, 5 sessions/week, lasting 2 weeks)

Other Outcome Measures

Outcome Measure
Time Frame
Change in working memory ability as assessed by N-back task after intervention
Time Frame: Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.
Assessments will be conducted before the treatment, weekly during the treatment period (at the end of the first and second weeks), and a follow-up evaluation will be performed one week after the conclusion of the treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 3, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

January 2, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 9, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202312116DINB

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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