Continuous Theta Burst Stimulation for Generalized Anxiety Disorder

NCT07770919 | Not Yet Recruiting

• 1 other identifier: KCB-TT.15-GAD
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial evaluates the effectiveness of continuous theta burst stimulation (cTBS) combined with background pharmacotherapy in patients with generalized anxiety disorder. Participants will be randomly assigned to receive cTBS targeting either the right posterior parietal cortex or the right dorsolateral prefrontal cortex. The study will compare changes in anxiety symptoms between the two treatment strategies and will also assess quality of life, sleep, cognitive function, electroencephalographic measures, and transcranial magnetic stimulation-electroencephalography measures.

Conditions

Generalized Anxiety Disorder

Keywords

Generalized Anxiety Disorder; Continuous Theta Burst Stimulation; cTBS; Transcranial Magnetic Stimulation; Posterior Parietal Cortex; Dorsolateral Prefrontal Cortex

Outcome Measures

Primary Outcomes (1)

• Change in Hamilton Anxiety Rating Scale (HAM-A) Total Score

  The Hamilton Anxiety Rating Scale (HAM-A) is used to assess the severity of anxiety symptoms. The scale consists of 14 items, each rated from 0 to 4, yielding a total score ranging from 0 to 56, with higher scores indicating greater anxiety severity. The primary outcome is the change in HAM-A total score from baseline (T0) to the end-of-treatment assessment (T4).

  Baseline (T0) to end of treatment (T4), assessed 24-72 hours after the final treatment session

Secondary Outcomes (5)

• Change in World Health Organization Quality of Life-BREF (WHOQOL-BREF) Scores

  Baseline (T0) to end of treatment (T4), assessed 24-72 hours after the final treatment session

• Change in Pittsburgh Sleep Quality Index (PSQI) Global Score

  Baseline (T0) to end of treatment (T4), assessed 24-72 hours after the final treatment session

• Change in Montreal Cognitive Assessment (MoCA) Total Score

  Baseline (T0) to end of treatment (T4), assessed 24-72 hours after the final treatment session

• Change in Mini-Mental State Examination (MMSE) Total Score

  Baseline (T0) to end of treatment (T4), assessed 24-72 hours after the final treatment session

• Incidence of Treatment-Emergent Adverse Events

  From the first treatment session through the end-of-treatment assessment (T4)

Other Outcomes (2)

• Change in Individual Alpha Frequency (IAF)

  Baseline (T0) and 24-72 hours after the final treatment session (T4)

• Changes in TMS-EEG Measures

  Baseline (T0) and 24-72 hours after the final treatment session (T4)

Study Arms (2)

cTBS Right Posterior Parietal Cortex

EXPERIMENTAL

Participants receive continuous theta burst stimulation (cTBS) targeting the right posterior parietal cortex (R-PPC) in addition to background pharmacotherapy. The treatment course consists of 10 cTBS sessions delivered over approximately 1 week.

Device: Continuous Theta Burst Stimulation of the Right Posterior Parietal Cortex

cTBS Right Dorsolateral Prefrontal Cortex

EXPERIMENTAL

Participants receive continuous theta burst stimulation (cTBS) targeting the right dorsolateral prefrontal cortex (R-DLPFC) in addition to background pharmacotherapy. The treatment course consists of 20 cTBS sessions delivered over approximately 4 weeks.

Device: Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal Cortex

Interventions

Continuous Theta Burst Stimulation of the Right Posterior Parietal Cortex DEVICE

Continuous theta burst stimulation (cTBS) is delivered to the right posterior parietal cortex (R-PPC) at 80% of the active motor threshold (AMT). Participants receive 10 treatment sessions over approximately 1 week, in addition to stable background pharmacotherapy.

cTBS Right Posterior Parietal Cortex

Continuous Theta Burst Stimulation of the Right Dorsolateral Prefrontal Cortex DEVICE

Continuous theta burst stimulation (cTBS) is delivered to the right dorsolateral prefrontal cortex (R-DLPFC) at 80% of the active motor threshold (AMT). Participants receive 20 treatment sessions over approximately 4 weeks, in addition to stable background pharmacotherapy.

cTBS Right Dorsolateral Prefrontal Cortex

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 59 years.
• Diagnosis of generalized anxiety disorder (GAD; ICD-10 F41.1) according to DSM-5 diagnostic criteria.
• Hamilton Anxiety Rating Scale (HAM-A) total score \>18 at screening.
• Able to understand the study procedures and provide written informed consent.

You may not qualify if:

• History of epilepsy or seizures.
• Presence of metal or implanted electronic devices that are contraindications to transcranial magnetic stimulation (TMS), including relevant intracranial metallic implants or cardiac pacemakers.
• Pregnancy.
• Acute psychotic symptoms or high suicide risk.
• Current substance abuse or dependence that may interfere with study participation.
• Major structural brain lesions that, in the investigator's judgment, may affect study participation or outcome assessment.
• Any other medical or neurological condition that, in the investigator's judgment, makes participation unsafe or may substantially interfere with study procedures.

Sponsors & Collaborators

• Military Hospital 175: lead

Study Sites (1)

Military Hospital 175

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Dang Minh Ly, MD

CONTACT

+84359999741; drminhdang@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors are blinded to treatment allocation. Participants and personnel administering the intervention are not blinded because the two treatment strategies differ in stimulation target and treatment schedule.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Neurology

Model Details: Participants with generalized anxiety disorder are randomly assigned to one of two parallel treatment groups receiving continuous theta burst stimulation (cTBS) targeting either the right posterior parietal cortex (R-PPC) or the right dorsolateral prefrontal cortex (R-DLPFC), in addition to background pharmacotherapy.

Study Record Dates

• First Submitted: August 13, 2026
• First Posted: August 18, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 18, 2026

Record last verified: 2026-08

Locations

VN (1)