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Enrolling by invitation NCT06931236

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

No phase Interventional Generalized Anxiety Disorder (GAD) Insomnia Repetitive Transcranial Magnetic Stimulation (rTMS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Repetitive Transcranial Magnetic Stimulation, Sham Repetitive Transcranial Magnetic Stimulation.
Who it may be relevant to
Registry conditions: Generalized Anxiety Disorder (GAD), Insomnia, Repetitive Transcranial Magnetic Stimulation (rTMS). Basic parameters: 15 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

Interventions

  • Device Repetitive Transcranial Magnetic Stimulation
    Repetitive transcranial magnetic stimulation (rTMS) can noninvasively modulate cortical activity by delivering a sequence of magnetic pulses.
  • 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°.

Primary outcome measures

  • subjective sleep quality assessed by the PSQI [Time frame: 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]
  • emotional symptoms assessed by the HAMA [Time frame: before and after 10-day intervention and at 1-month follow-up]
Secondary outcome measures (1)
  • emotional symptoms assessed by the HAMD [Time frame: before and after 10-day intervention and at 1-month follow-up]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Anhui Medical University — Hefei

Identifiers

NCT: NCT06931236 · AHMU-TMS-GADIS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗