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

Yi Yang

Status: Not yet enrolling

Conditions: Generalized Anxiety Disorder

Treatments: Device: Repetitive Transcranial Magnetic Stimulation; Device: Sham Repetitive Transcranial Magnetic Stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05883774

TMS-GAD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

rTMS

Active Comparator group

Description:

Patients are treated with repetitive transcranial magnetic stimulation (rTMS).

Treatment:

Device: Repetitive Transcranial Magnetic Stimulation

sham-rTMS

Sham Comparator group

Description:

Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).

Treatment:

Device: Sham Repetitive Transcranial Magnetic Stimulation