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

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05883774
• Other study ID #: TMS-GAD
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: February 2024
• Source: The First Hospital of Jilin University
• Contact: Yi Yang, MD, PhD
• Phone: 13756661217
• Email: doctor_yangyi[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: January 1, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

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).
• 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.

Locations

Country	Name	City	State
China	First Hospital of Jilin University	Changchun	Jilin

Sponsors (1)

Lead Sponsor	Collaborator
Yi Yang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline; 10 days