An interventional study of Repetitive Transcranial Magnetic Stimulation and Sham Repetitive Transcranial Magnetic Stimulation in Generalized Anxiety Disorder (GAD), Insomnia and Repetitive Transcranial Magnetic Stimulation (rTMS), sponsored by Yanghua Tian. Enrolling by invitation at 1 site in China. Open to participants aged 15 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-17.
Sponsored by Yanghua Tian · Not applicable, Interventional, and Treatment
To investigate the intervention effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on insomnia symptoms of generalized anxiety disorder patients.
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.
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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
sham rTMS is carried out as the coil is turned away from the skull at 90°.
Device: Sham Repetitive Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation (rTMS) can noninvasively modulate cortical activity by delivering a sequence of magnetic pulses.
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°.
subjective sleep quality assessed by the PSQI
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.
Time frame: before and after 10-day intervention and at 1-month follow-up
subjective sleep quality assessed by the ISI
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.
Time frame: before and after 10-day intervention and at 1-month follow-up
emotional symptoms assessed by the HAMA
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.
Time frame: before and after 10-day intervention and at 1-month follow-up
emotional symptoms assessed by the HAMD
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.
Time frame: before and after 10-day intervention and at 1-month follow-up
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