Generalized Anxiety Disorder (GAD), Insomnia, Repetitive Transcranial Magnetic Stimulation (rTMS)
Conditions
Keywords
generalized anxiety disorder, insomnia, Repetitive Transcranial Magnetic Stimulation
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.
Interventions
DEVICERepetitive Transcranial Magnetic Stimulation
Repetitive transcranial magnetic stimulation (rTMS) can noninvasively modulate cortical activity by delivering a sequence of magnetic pulses.
DEVICESham 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°.
Sponsors
Yanghua Tian
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| subjective sleep quality assessed by the PSQI | 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. |
| subjective sleep quality assessed by the ISI | 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. |
| emotional symptoms assessed by the HAMA | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| emotional symptoms assessed by the HAMD | 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. |
Countries
China
Outcome results
None listed