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

NCT05883774 | Not Yet Recruiting

• 1 other identifier: TMS-GAD
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Generalized Anxiety Disorder

Keywords

repetitive transcranial magnetic stimulation; generalized anxiety disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

rTMS

ACTIVE COMPARATOR

Patients are treated with repetitive transcranial magnetic stimulation (rTMS).

Device: Repetitive Transcranial Magnetic Stimulation

sham-rTMS

SHAM COMPARATOR

Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).

Device: Sham Repetitive Transcranial Magnetic Stimulation

Interventions

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).

Also known as: rTMS

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.

Also known as: sham-rTMS

sham-rTMS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ）Age≥60 years, regardless of gender.
• ）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.
• ）HAMA score≥14 and HAMD-17 items score \<17.
• ）No adjustment in the type and dose of anti-anxiety medication in the 3 months prior to randomization.
• ）Willing to participate and sign the informed consent.

You may not qualify if:

• ）Traumatic brain injury or other conditions affecting the brain, such encephalitis, brain tumors, or intracranial hypertension.
• ）Previous history of epilepsy, family history of epilepsy or presence of seizure provoking factors or alcohol abuse.
• ）History of other psychiatric disorders such as current post-traumatic stress disorder, substance use disorder (within 6 months), bipolar disorder and obsessive-compulsive disorder.
• ）Unstable mental state with impulses toward self-harm or suicide.
• ）Presence of intracranial metal implant, cochlear implant, built-in pulse generator (such as cardiac pacemaker), etc.
• ）Medical or surgical disorders that are severe or unstable.
• ）Pregnancy or breastfeeding.
• \) 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.
• \) Other conditions that the researchers think are not suitable for the project.

Sponsors & Collaborators

• Yi Yang: lead

Study Sites (1)

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Yi Yang, MD, PhD

CONTACT

13756661217; doctor_yangyi@163.com

Zhen-Ni Guo, MD, PhD

CONTACT

18186872986; zhen1ni2@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice President of First Hospital of Jilin University

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 1, 2023
• Study Start: December 1, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: October 2, 2024

Record last verified: 2024-10

Locations

CN (1)