Effects of rTMS on the Anxiety State of Older Patients With GAD
NCT ID: NCT05883774
Last Updated: 2024-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
100 participants
INTERVENTIONAL
2024-12-01
2025-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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rTMS
Patients are treated with repetitive transcranial magnetic stimulation (rTMS).
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).
sham-rTMS
Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).
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.
Interventions
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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).
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
60 Years
ALL
No
Sponsors
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Yi Yang
OTHER
Responsible Party
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Yi Yang
Vice President of First Hospital of Jilin University
Locations
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First Hospital of Jilin University
Changchun, Jilin, China
Countries
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Central Contacts
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Other Identifiers
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TMS-GAD
Identifier Type: -
Identifier Source: org_study_id
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