Neuroimage-guided Dual-target Continuous Theta Burst Stimulation for Generalized Anxiety Disorder

NCT06699706 | Active Not Recruiting

• 1 other identifier: AHMU-cTBS-anxiety
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this clinical trial was to determine whether image-guided dual-target cTBS is effective for anxiety disorders. The main questions it aims to answer are:

1. 1.Does dual-target cTBS improve patients' anxiety symptoms?
2. 2.Does dual-target cTBS improve patients' somatization symptoms?
3. 3.Researchers will compare cTBS real and sham stimulation to determine whether cTBS is effective in treating anxiety disorders.
4. 4.Received either cTBS treatment or sham stimulation for 7 consecutive days
5. 5.Psychological assessment and MRI scan were performed before treatment, within 2 days, 2 weeks and 1 month after treatment
6. 6.Adverse reactions during the experiment were recorded

Conditions

Anxiety; Transcranial Magnetic Stimulation Repetitive

Keywords

Transcranial Magnetic Stimulation; anxiety; neuroimage

Outcome Measures

Primary Outcomes (1)

• Hamilton Anxiety Rating Scale (HAMA)

  the change of anxiety symptoms assessed by HAMA scale(Hamilton Anxiety Scale) will constitute the major research outcome measure, to assess response to tACS. HAMA scale scores range from 0 to 56 points, the higher the score indicates the more serious anxiety symptoms

  0week, 1week, 3week, 5week

Secondary Outcomes (6)

• Hamilton Depression Rating Scale (HAMD)

  0week, 1week, 3week, 5week

• Patient Health Questionnaire (PHQ-15)

  0week, 1week

• Self-rating anxiety scale(SAS)

  0week, 1week

• ISI(The insomnia severity index)

  0week, 1week

• Attention Network Test (ANT)

  0week, 1week

Study Arms (2)

active cTBS group

ACTIVE COMPARATOR

Dual-target active cTBS will be performed over 7 consecutive days

Other: Continuous theta-burst stimulation

sham cTBS group

SHAM COMPARATOR

Sham stimulation of dual-target cTBS was performed for 7 consecutive days using a sham coil

Other: sham continuous theta-burst stimulation

Interventions

Continuous theta-burst stimulation OTHER

cTBS targets two regions: the dorsolateral prefrontal cortex (dlPFC) and the M1 area. Before the first treatment, each participant's resting motor threshold (RMT) will be determined using a five-step procedure for the primary motor cortex. RMT is defined as the minimum intensity required to elicit a motor response greater than 50 µV in at least 5 out of 10 consecutive trials in the right first dorsal interosseous muscle. Participants will then undergo daily cTBS treatment three times a day for 7 consecutive days. Each stimulation session lasts 40 seconds, consisting of triplets of 50 Hz theta-burst stimulation repeated at 5 Hz, delivering a total of 600 pulses. Stimulation of the dlPFC target will be immediately followed by stimulation of the M1 target. To achieve cumulative aftereffects, the protocol will be repeated three times per day (a total of 3600 pulses/day) with two 15-minute breaks between sessions, timed with a stopwatch.

active cTBS group

sham continuous theta-burst stimulation OTHER

The treatment pattern for the sham continuous theta-burst stimulation was similar to that for real stimulation. The sham coil is identical in appearance to the active coil, but it only produces sounds and sensations similar to those of the active coil on the scalp without generating a current, preventing participants from identifying their group assignment.

sham cTBS group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• the patients were diagnosed by more than 2 psychiatrists and met the diagnostic criteria of DSM-5 for anxiety
• HAMA score ≥ 14 (HAMD score \< 17).
• Age range: 18-60 years.
• Right-handed.
• Able to cooperate with the collection of general demographic information and neuropsychological testing.
• Patients are either medication-free or maintain a consistent medication regimen during cTBS treatment.-

You may not qualify if:

• Presence of organic brain lesions detected on MRI.
• History of alcohol or drug dependence.
• Diagnosis of other neuropsychiatric disorders, such as epilepsy, autism, obsessive-compulsive disorder, or autoimmune encephalitis.
• Contraindications to MRI scanning.-

Sponsors & Collaborators

• Anhui Medical University: lead

Study Sites (1)

Cognitive Neuropsychology Lab Anhui Medical University

Hefei, Anhui, China

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

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: phD

Study Record Dates

• First Submitted: November 19, 2024
• First Posted: November 21, 2024
• Study Start: November 1, 2024
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)