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

ConditionGeneralized Anxiety Disorder

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age60+

SponsorYi Yang

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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).
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: rTMSActive comparator 1 intervention

Group B: sham-rTMSSham comparator 1 intervention

Trial outcomes

Primary outcomes

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

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.

Time frame

baseline; 10 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Yi Yang

Lead sponsor

The First Hospital of Jilin University

Sponsor institution

Source ClinicalTrials.gov

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