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| Name | Class |
|---|---|
| Stanford University | OTHER |
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Rumination is significantly frequent in major depressive disorder. However, not a lot of studies have investigated the effects of repetitive transcranial magnetic stimulation on rumination and its electrophysiological correlates. This study recruited 61 participants who were randomly assigned to sham, bilateral, or unilateral stimulation groups to investigate the potential differences between these stimulation protocols and changes in the behavioral and electrophysiological outcomes after treatment.
This study aims to compare the effect of unilateral and bilateral rTMS on the reduction of rumination and anhedonia and their associated neural networks. In a randomized double-blind trial, 65 patients with depressive disorder in Atieh Clinical Neuroscience Center are assigned to three groups. The first group receives bilateral rTMS for 20 sessions on right and left DLPFC; the second group receives unilateral rTMS for 20 sessions on LDLPFC; third group receives sham rTMS for 10 sessions. In this group, the stimulation parameters are similar to that in the actual rTMS group, except that the coil angel is 90ยฐ and perpendicular to the head. Rumination and anhedonia symptoms will be measured by the Ruminative Responses Scale (RRS) and Snaith-Hamilton Pleasure Scale (SHAPS) in the baseline and after the 20th session. In order to investigate the neural networks associated with rumination and anhedonia, EEG of patients will be recorded at the first session and at the end of the treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| bilateral rTMS | Active Comparator | sequential bilateral repetitive Transcranial Magnetic Stimulation (rTMS) |
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| Sham rTMS | Sham Comparator | Sham Transcranial Magnetic Stimulation (rTMS) |
|
| Unilateral rTMS | Active Comparator | Unilateral (High frequency) repetitive Transcranial Magnetic Stimulation (rTMS) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral rTMS | Device | The coil will locate on F3 and F4 in accordance with the 10-20 international system. bilateral rTMS include stimulate the right DLPFC at 1 Hz for a 10 seconds train of stimulation, and a total of 150 pulse trains. Immediately after that, the stimulation was carried out on the left DLPFC at 10 Hz, 5 seconds of stimulation, with 10 second inter-train interval and 75 pulse trains. |
| Measure | Description | Time Frame |
|---|---|---|
| Rumination Symptoms | The Ruminative Responses Scale (RRS) is a measure of depressive rumination which has two subscales: Both subscales are composed of five items. Brooding and Reflection. Higher score indicate a higher level of ruminative responses (range: 22-88). | baseline before start of treatment and immediately after the last treatment session. |
| changes in default mode network | EEG | baseline before start of treatment and immediately after the last treatment session. |
| Anhedonia Symptoms | Snaith-Hamilton Pleasure Scale (SHAPS), a measure of anhedonia | baseline before start of treatment and immediately after the last treatment session. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms measured by the 17-item Hamilton Depression Rating Scale | Hamilton Depression Rating Scale (HDRS),(HRSD17) Range: 0-53 Normal: 0-7 Mild: 8 - 13 Moderate 14 - 18 Severe: 19-22 Very severe > 22 | baseline before start of treatment and immediately after the last treatment session. |
| Depressive symptoms measured by the 21-item Beck Depression Inventory-II |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Reza Kazemi, PhD | Atieh Clinical Neuroscience center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atieh Clinical Neuroscience Center (ACNC) | Tehran | 1969713663 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36055535 | Result | Kazemi R, Rostami R, Nasiri Z, Hadipour AL, Kiaee N, Coetzee JP, Philips A, Brown R, Seenivasan S, Adamson MM. Electrophysiological and behavioral effects of unilateral and bilateral rTMS; A randomized clinical trial on rumination and depression. J Affect Disord. 2022 Nov 15;317:360-372. doi: 10.1016/j.jad.2022.08.098. Epub 2022 Aug 30. |
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| ID | Term |
|---|---|
| D003865 | Depressive Disorder, Major |
| D001714 | Bipolar Disorder |
| D000079562 | Rumination Syndrome |
| D059445 | Anhedonia |
| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
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| Sham rTMS | Device | The same parameters will use in the sham rTMS. However, the coil adjust at an angle of 90ยบ vertically on the skull in a way that one wing place on the head. |
|
| Unilateral rTMS (High frequency) | Device | The coil will locate on F3 in accordance with the 10-20 international system. Unilateral rTMS include stimulate the Left DLPFC at 10Hz for a 5seconds train of stimulation, 10 seconds inter-train interval, and a total of 75 pulse trains. . |
|
Beck Depression Inventory-II (BDI-II), (BDI-II) Range: 0-63 Normal: 0-13 Mild: 14- 9 Moderate 20- 28 Severe: 29-63 |
| baseline before start of treatment and immediately after the last treatment session. |
| D005767 |
| Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D001068 | Feeding and Eating Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |