Generalized Anxiety DisorderNCT05883774
Effects of rTMS on the Anxiety State of Older Patients With GAD
A study testing Repetitive Transcranial Magnetic Stimulation in people with Generalized Anxiety Disorder, run by Yi Yang at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Repetitive Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Repetitive Transcranial Magnetic Stimulation on the Anxiety State of Older Patients With Generalized Anxiety Disorder
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.
Read the 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation
- Keywords
- repetitive transcranial magnetic stimulation, generalized anxiety disorder
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive Transcranial Magnetic StimulationDevice
Also called rTMS
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 StimulationDevice
Also called sham-rTMS
Sham-rTMS is performed in the same way as the treatment group except that the coil is rotated 90° away from the scalp.
| Study group | Role | What they receive |
|---|---|---|
| rTMS | Active comparator | Patients are treated with repetitive transcranial magnetic stimulation (rTMS). Receives: Device: Repetitive Transcranial Magnetic Stimulation |
| sham-rTMS | Sham comparator | Patients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS). Receives: Device: Sham Repetitive Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline; 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Dec 2024 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yi Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yi Yang, The First Hospital of Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05883774
- Sponsor's protocol ID
- TMS-GAD
- Status last verified
- Oct 2024
- First submitted
- 22 May 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Repetitive Transcranial Magnetic Stimulation on the Anxiety State of Older Patients With Generalized Anxiety Disorder
- ClinicalTrials.gov ID
- NCT05883774
- Acronym / sponsor ID
- TMS-GAD
- Conditions
- Generalized Anxiety Disorder
- Keywords
- repetitive transcranial magnetic stimulation, generalized anxiety disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yi YangUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rTMS | Active comparator | Device: Repetitive Transcranial Magnetic StimulationPatients are treated with repetitive transcranial magnetic stimulation (rTMS). |
| sham-rTMS | Sham comparator | Device: Sham Repetitive Transcranial Magnetic StimulationPatients are treated with sham repetitive transcranial magnetic stimulation (sham-rTMS). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive Transcranial Magnetic StimulationAlso: rTMSrTMS 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). | Device | rTMS |
| Sham Repetitive Transcranial Magnetic StimulationAlso: sham-rTMSSham-rTMS is performed in the same way as the treatment group except that the coil is rotated 90° away from the scalp. | Device | sham-rTMS |
Primary outcome
Differences in HAMA scores after 10 sessions of rTMS/sham-rTMS between two groups.
Time frame: baseline; 10 days
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive Transcranial Magnetic Stimulation in people with Generalized Anxiety Disorder, run by Yi Yang at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Yang, MD, PhD (13756661217 ext. 0086, doctor_yangyi@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in HAMA scores after 10 sessions of rTMS/sham-rTMS between two groups. (time frame: baseline; 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.