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

Primary Purpose

Generalized Anxiety Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Repetitive Transcranial Magnetic Stimulation
Sham Repetitive Transcranial Magnetic Stimulation
Sponsored by
Yi Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder focused on measuring repetitive transcranial magnetic stimulation, generalized anxiety disorder

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

rTMS

sham-rTMS

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 22, 2023
Last Updated
June 1, 2023
Sponsor
Yi Yang
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1. Study Identification

Unique Protocol Identification Number
NCT05883774
Brief Title
Effects of rTMS on the Anxiety State of Older Patients With GAD
Official Title
Effects of Repetitive Transcranial Magnetic Stimulation on the Anxiety State of Older Patients With Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Yi Yang

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
Keywords
repetitive transcranial magnetic stimulation, generalized anxiety disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
rTMS
Arm Type
Active Comparator
Arm Description
Patients are treated with repetitive transcranial magnetic stimulation (rTMS).
Arm Title
sham-rTMS
Arm Type
Sham Comparator
Arm Description
Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS).
Intervention Type
Device
Intervention Name(s)
Repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
rTMS
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Sham Repetitive Transcranial Magnetic Stimulation
Other Intervention Name(s)
sham-rTMS
Intervention Description
Sham-rTMS is performed in the same way as the treatment group except that the coil is rotated 90° away from the scalp.
Primary Outcome Measure Information:
Title
Differences in HAMA scores after 10 sessions of rTMS/sham-rTMS between two groups.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yi Yang, MD, PhD
Phone
13756661217
Ext
0086
Email
doctor_yangyi@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhen-Ni Guo, MD, PhD
Phone
18186872986
Ext
0086
Email
zhen1ni2@163.com
Facility Information:
Facility Name
First Hospital of Jilin University
City
Changchun
State/Province
Jilin
ZIP/Postal Code
130000
Country
China

12. IPD Sharing Statement

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

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