Effects of rTMS on the Anxiety State of Older Patients With GAD

Not Applicable

Not yet recruiting

• Conditions: Generalized Anxiety Disorder
• Interventions: Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Repetitive Transcranial Magnetic Stimulation

• Registration Number: NCT05883774
• Lead Sponsor: Yi Yang

Brief Summary

The purpose of this study is to evaluate the effects of low-frequency repetitive transcranial magnetic stimulation on anxiety state in older patients with generalized anxiety disorder.

Detailed Description

Repetitive transcranial magnetic stimulation can alter nerve cell excitability, improve cerebral blood flow and metabolism, and is widely used in neuropsychiatric research. Studies have shown its efficiency and safety in treating anxiety disorders, however the senior patient group has not been adequately validated. The purpose of this study is to evaluate the effects of low-frequency repetitive transcranial magnetic stimulation on anxiety state in older patients with generalized anxiety disorder.

Study Timeline

• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-01
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-01
• Last Update Posted: 2024-10-02
• Study Start: 2024-12-01
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 1）Age≥60 years, regardless of gender.
• 2）Meets the diagnostic criteria for generalized anxiety disorder in the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-V) developed by the American Psychiatric Association.
• 3）HAMA score≥14 and HAMD-17 items score <17.
• 4）No adjustment in the type and dose of anti-anxiety medication in the 3 months prior to randomization.
• 5）Willing to participate and sign the informed consent.

Exclusion Criteria

• 1）Traumatic brain injury or other conditions affecting the brain, such encephalitis, brain tumors, or intracranial hypertension.
• 2）Previous history of epilepsy, family history of epilepsy or presence of seizure provoking factors or alcohol abuse.
• 3）History of other psychiatric disorders such as current post-traumatic stress disorder, substance use disorder (within 6 months), bipolar disorder and obsessive-compulsive disorder.
• 4）Unstable mental state with impulses toward self-harm or suicide.
• 5）Presence of intracranial metal implant, cochlear implant, built-in pulse generator (such as cardiac pacemaker), etc.
• 6）Medical or surgical disorders that are severe or unstable.
• 7）Pregnancy or breastfeeding.
• 8. Those who are participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to enrollment.
• 9. Other conditions that the researchers think are not suitable for the project.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
rTMS	Repetitive Transcranial Magnetic Stimulation	Patients are treated with repetitive transcranial magnetic stimulation (rTMS).
sham-rTMS	Sham Repetitive Transcranial Magnetic Stimulation	Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).

Primary Outcome Measures

Name	Time	Method
Differences in HAMA scores after 10 sessions of rTMS/sham-rTMS between two groups.	baseline; 10 days	The HAMA scale consists of 14 items, each with a score ranging from 1 to 4, for a total score ranging from 14 to 56, and the degree of anxiety correlates positively with the score.

Trial Locations

Locations (1)

First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China