Clinical Efficacy and Mechanism of rTMS Based on dlPFC in the Intervention of Generalized Anxiety Disorder With Insomnia

April 9, 2025 updated by: Yanghua Tian

Clinical Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation Based on dlPFC in the Intervention of Generalized Anxiety Disorder With Insomnia: An Open-label Study

To investigate the intervention effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on insomnia symptoms of generalized anxiety disorder patients.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

Stimulation was performed using a figure 8-shaped focal coil attached to a MagPro 100 magnetic stimulator (MagVenture, Copenhagen, Denmark). All patients received 1 Hz (10 s trains, 1 s inter-train interval, 1,360 pulses per session) rTMS treatment once daily on weekdays for 2 consecutive weeks. rTMS was delivered over the right DLPFC (F4 electrode site according to the International 10-20 EEG system) at 100% of the resting motor threshold (RMT) . To determine the RMT, stimulus intensity was gradually increased until 5 out of 10 trials elicited motor evoked potentials with peak-to-peak amplitudes over 50 μV in the contralateral abductor pollicis brevis muscle. Adverse events attributed to rTMS were documented and reported. All participants received a pre-treatment assessment with the PSQI, HAMA, and HAMD. We used the PSQI to measure sleep quality, as well as HAMA and HAMD to assess participant's anxious and depressive states. Likewise, the PSQI was measured post-treatment (upon completion of the final treatment session) and at 1-month follow-up.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Hefei, Anhui, China
        • Anhui Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age between 15 and 65 years;
  2. clinically diagnosed with anxiety according to the Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V);
  3. no previous application of any insomnia pharmacological therapy for at least one week before baseline visit.

Exclusion Criteria:

  1. current or history of serious brain and body diseases;
  2. current or history of schizophrenia, behavioral problems, post-traumatic stress disorder, mania, obsessive-compulsive disorder, and social phobia;
  3. substance abuse or other comorbid psychological diseases.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: real stimulation
Stimulation was performed using a figure 8-shaped focal coil attached to a MagPro 100 magnetic stimulator (MagVenture, Copenhagen, Denmark). All patients received 1 Hz (10 s trains, 1 s inter-train interval, 1,360 pulses per session) rTMS treatment once daily on weekdays for 2 consecutive weeks. rTMS was delivered over the right DLPFC (F4 electrode site according to the International 10-20 EEG system) at 100% of the resting motor threshold (RMT).
Device: Repetitive Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation (rTMS) can noninvasively modulate cortical activity by delivering a sequence of magnetic pulses.
Sham Comparator: sham stimulation
sham rTMS is carried out as the coil is turned away from the skull at 90°.
Device: Sham Repetitive Transcranial Magnetic Stimulation
Sham tDCS was delivered using the same protocol and current intensity, but it is carried out as the coil is turned away from the skull at 90°.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
subjective sleep quality assessed by the PSQI
Time Frame: before and after 10-day intervention and at 1-month follow-up
The Pittsburgh Sleep Quality Index (PSQI) consist of 18 items divided into 7 dimensions, such as sleep duration, sleep efficiency, sleep disorders and daytime dysfunction. The PSQI total score ranges from 0 to 21, the higher the score indicates the more worse sleep quality.
before and after 10-day intervention and at 1-month follow-up
subjective sleep quality assessed by the ISI
Time Frame: before and after 10-day intervention and at 1-month follow-up
The Insomnia Severity Index (ISI) is a 7-item scale to measure insomnia symptoms, where each item is rated on a scale from 0 to 4. The ISI total score ranges from 0 to 28, The higher the score indicates the more worse sleep quality.
before and after 10-day intervention and at 1-month follow-up
emotional symptoms assessed by the HAMA
Time Frame: before and after 10-day intervention and at 1-month follow-up
The HAMA is a 14-item scale to measure the severity of anxiety symptoms, where each item is rated on a scale from 0 to 4. The HAMA total score ranges from 0 to 56, with lower scores indicating less anxiety symptoms.
before and after 10-day intervention and at 1-month follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
emotional symptoms assessed by the HAMD
Time Frame: before and after 10-day intervention and at 1-month follow-up
The HAMD is a clinic ian-administered depression assessment and consists of 17 items with a total score range from 0 to 54. A higher score indicates a worse outcome.
before and after 10-day intervention and at 1-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yanghua Tian

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2024

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 30, 2025

First Submitted That Met QC Criteria

April 9, 2025

First Posted (Actual)

April 17, 2025

Study Record Updates

Last Update Posted (Actual)

April 17, 2025

Last Update Submitted That Met QC Criteria

April 9, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHMU-TMS-GADIS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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