Anhui Medical University
Hefei, Anhui, China
NCT Number: NCT06931236
To investigate the intervention effect of Repetitive Transcranial Magnetic Stimulation (rTMS) on insomnia symptoms of generalized anxiety disorder patients.
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Request Info15 year–65 year
All sexes
Interventional
Not applicable
Hefei, Anhui, China
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.
Healthy volunteers accepted: No
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Inclusion criteria
Exclusion criteria
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°.
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.
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.
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.
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.
Yanghua Tian
Other
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
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