To investigate the intervention effect of high definition transcranial direct current stimulation (HD-tDCS) on somatic symptoms in patients with depressive disorder and its underlying neural mechanism by MRI.
Depressive disorder is a major public health and safety problem around the world. Patients with depression often performe symptoms such as anhedonia, lack of motivation, somatic symptoms, and even suicidal ideation and behavior. The purpose of this study was to study the relieving effect of high definition transcranial direct current stimulation (HD-tDCS) on the symptoms of depression. 60 patients with depressive disorder diagnosed by DSM-5 were recruited from the fourth people's Hospital of Hefei and the first affiliated Hospital of Anhui Medical University. All participants underwent a structured interview and routine laboratory examination before and after receiving HD-tDCS. After meeting the inclusion criteria and obtaining informed consent. Each participant will complete the clinical evaluation, functional magnetic resonance imaging (fMRI) and HD-tDCS treatment conducted by trained researchers at the Neuropsychological Synergetic Innovation Center of Anhui Medical University. All the participants were randomized (1:1) to receive "active" or "sham" treatment protocol. The anode was placed over Fz with return electrodes placed at Fpz, Cz, F3 and F4. Fourteen 2-mA sessions (ramp-up and ramp-down periods of 30 and 30 seconds, respectively) were applied for 20 minutes each day over 14 consecutive sessions. Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds. Before and after the HD-tDCS treatment, the patients had receiving a battery measure of neuropsychological tests and Magnetic resonance imaging scan in multimodalities. Neuropsychological assessment included MoCA, Stroop Test, VFT, DST, AVLT, HAMD, HAMA, PHQ15, BSS(Beck scale for suicide ideation),ISI,SDS, RRS, TEPS, AES, FPQ, PVAQ and AAS. Multimodal fMRI includes 3D-T1, rs-fMRI, DTI and ASL. Neuropsychological evaluation and magnetic resonance imaging data were obtained again 24 hours after the last treatment. The symptoms of the patients were followed up one month after the end of treatment.They were instructed to focus their answers on the past week. Afterwards, they were unblinded by the study coordinator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
57
tDCS is described as a non-invasive form of brain stimulation that uses a low-intensity, constant current applied directly to the head through scalp electrodes.
Sham HD-tDCS was delivered using the same protocol and current intensity, but the period of active stimulation was only during the ramp-up and ramp-down periods of 30 and 30 seconds.
Anhui Medical University
Hefei, China
the change of somatic symptoms in active group and sham group at post-treatment and follow-up visit.
the somatic symptoms were assessed by PHQ-15 scale.
Time frame: Baseline, Week 2 and Week 8.
the percentage decrease in PHQ-15 scores in active group and sham group at post-treatment and follow-up visit.
The percentage of decrease in scores was measured using the following formula: (pretreatment scores - post-treatment scores)/pretreatment scores × 100 %).
Time frame: Baseline, Week 2 and Week 8.
the number of somatic responders in active group and sham group at post-treatment and follow-up visit.
Responders were defined as patients who had a ≥ 50% decrease in the PHQ-15 score.
Time frame: Baseline, Week 2 and Week 8.
the change of depressive symptoms in active group and sham group at post-treatment and follow-up visit.
the depressive symptoms were assessed by HAMD scale.
Time frame: Baseline, Week 2 and Week 8.
the percentage decrease in HAMD scores in active group and sham group at post-treatment and follow-up visit.
The percentage of decrease in scores was measured using the following formula: (pretreatment scores - post-treatment scores)/pretreatment scores × 100 %).
Time frame: Baseline, Week 2 and Week 8.
the number of depressive responders in active group and sham group at post-treatment and follow-up visit.
Responders were defined as patients who had a ≥ 50% decrease in the HAMD score.
Time frame: Baseline, Week 2 and Week 8.
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