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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| real stimulation | Active Comparator | 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). |
|
| sham stimulation | Sham Comparator | sham rTMS is carried out as the coil is turned away from the skull at 90°. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Repetitive Transcranial Magnetic Stimulation | Device | Repetitive transcranial magnetic stimulation (rTMS) can noninvasively modulate cortical activity by delivering a sequence of magnetic pulses. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | before and after 10-day intervention and at 1-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | before and after 10-day intervention and at 1-month follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Medical University | Hefei | Anhui | China |
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| Sham Repetitive Transcranial Magnetic Stimulation | Device | 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°. |
|
| ID | Term |
|---|---|
| D000098647 | Generalized Anxiety Disorder |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D050781 | Transcranial Magnetic Stimulation |
| ID | Term |
|---|---|
| D055909 | Magnetic Field Therapy |
| D013812 | Therapeutics |
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