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NCT05883774 | NOT YET RECRUITING | Generalized Anxiety Disorder

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

Y i yang

Information provided by (Responsible Party):

Y i 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.

Condition or disease

Generalized Anxiety Disorder

Intervention/treatment

Repetitive Transcranial Magnetic Stimulation

Sham Repetitive Transcranial Magnetic Stimulation

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 100 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : Effects of Repetitive Transcranial Magnetic Stimulation on the Anxiety State of Older Patients With Generalized Anxiety Disorder
Actual Study Start Date : 2024-12-01
Estimated Primary Completion Date : 2025-12-01
Estimated Study Completion Date : 2025-12-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 60 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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.
Effects of rTMS on the Anxiety State of Older Patients With GAD

Location Details

NCT05883774

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How to Participate

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Locations

Not yet recruiting

China, Jilin

First Hospital of Jilin University

Changchun, Jilin, China, 130000