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NCT Number: NCT05883774

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First Hospital of Jilin University

Changchun, Jilin, 130000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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).

Other names: rTMS

Sham repetitive transcranial magnetic stimulation

Device

Sham-rTMS is performed in the same way as the treatment group except that the coil is rotated 90° away from the scalp.

Other names: sham-rTMS

Primary outcomes

  1. Differences in HAMA scores after 10 sessions of rTMS/sham-rTMS between two groups.

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yi Yang, MD, PhD

CONTACT

[email protected]

13756661217 ext. 0086

Zhen-Ni Guo, MD, PhD

CONTACT

[email protected]

18186872986 ext. 0086

Sponsors and collaborators

Lead sponsor

Yi Yang

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 1, 2023
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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