Clinical trial NCT06931236: Clinical Efficacy and Mechanism of rTMS Based on dlPFC in the Intervention of Generalized Anxiety Disorder With Insomnia
Official title: 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Generalized Anxiety Disorder (GAD)
Insomnia
Repetitive Transcranial Magnetic Stimulation (rTMS)
Keywords: generalized anxiety disorder
insomnia
Repetitive Transcranial Magnetic Stimulation
Lead sponsor: The Second Hospital of Anhui Medical University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 30
Sex: ALL
Minimum age (years): 15
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: subjective sleep quality assessed by the PSQI
timeFrame: before and after 10-day intervention and at 1-month follow-up
measure: subjective sleep quality assessed by the ISI
timeFrame: before and after 10-day intervention and at 1-month follow-up
measure: emotional symptoms assessed by the HAMA
timeFrame: before and after 10-day intervention and at 1-month follow-up
Secondary outcomes:
measure: emotional symptoms assessed by the HAMD
timeFrame: before and after 10-day intervention and at 1-month follow-up
Other outcomes:
Locations:
city: Hefei
country: China
facility: Anhui Medical University
state: Anhui
Study officials:
References: