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Not yet recruiting NCT05883774

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

No phase Interventional Generalized Anxiety Disorder

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation.
Who it may be relevant to
Registry conditions: Generalized Anxiety Disorder. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Repetitive Transcranial Magnetic Stimulation on the Anxiety State of Older Patients With Generalized Anxiety Disorder

Overview

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.

Interventions

  • Device Repetitive Transcranial Magnetic Stimulation
    rTMS is applied using a transcranial magnetic stimulator with a figure-of-8 coil once per day for 10 consecutive days. rTMS is delivered to the right dorsolateral prefrontal cortex (DLPFC) at a frequency of 1 Hz for 20 minutes (1200 total pulses).
  • Device Sham Repetitive Transcranial Magnetic Stimulation
    Sham-rTMS is performed in the same way as the treatment group except that the coil is rotated 90° away from the scalp.

Primary outcome measures

  • Differences in HAMA scores after 10 sessions of rTMS/sham-rTMS between two groups. [Time frame: baseline; 10 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • First Hospital of Jilin University — Changchun

Identifiers

NCT: NCT05883774 · TMS-GAD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗