Clinical trial NCT05883774: Effects of rTMS on the Anxiety State of Older Patients With GAD
Official title: Effects of Repetitive Transcranial Magnetic Stimulation on the Anxiety State of Older Patients With Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Generalized Anxiety Disorder
Keywords: repetitive transcranial magnetic stimulation
generalized anxiety disorder
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2023-06-01
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Differences in HAMA scores after 10 sessions of rTMS/sham-rTMS between two groups.
timeFrame: baseline; 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Changchun
country: China
facility: First Hospital of Jilin University
state: Jilin
Study officials:
References: