The Study of Effectiveness of rTMS on Rumination and Anhedonia in Patients With Major Depressive Disorder

NCT ID: NCT03468686

Last Updated: 2022-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-21
• Study Completion Date: 2020-10-30

Brief Summary

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.

Detailed Description

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 90° 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.

Conditions

Major Depressive Disorder; Bipolar Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

bilateral rTMS

sequential bilateral repetitive Transcranial Magnetic Stimulation (rTMS)

Group Type: ACTIVE_COMPARATOR

Bilateral rTMS

Intervention Type: 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.

Sham rTMS

Sham Transcranial Magnetic Stimulation (rTMS)

Group Type: SHAM_COMPARATOR

Sham rTMS

Intervention Type: DEVICE

The same parameters will use in the sham rTMS. However, the coil adjust at an angle of 90º vertically on the skull in a way that one wing place on the head.

Unilateral rTMS

Unilateral (High frequency) repetitive Transcranial Magnetic Stimulation (rTMS)

Group Type: ACTIVE_COMPARATOR

Unilateral rTMS (High frequency)

Intervention Type: 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. .

Interventions

Bilateral rTMS

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.

Intervention Type: DEVICE

Sham rTMS

The same parameters will use in the sham rTMS. However, the coil adjust at an angle of 90º vertically on the skull in a way that one wing place on the head.

Intervention Type: DEVICE

Unilateral rTMS (High frequency)

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. .

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Outpatients male and female with the range of 18-65 years of age
• The diagnosis of Major depressive disorder according to DSM-V
• Having BDI>18
• Having stable symptoms as defined by not requiring a change in medication for at least 4 weeks
• Completion of consent form
• Being under supervision of a psychiatrist

Exclusion Criteria

• The history of rTMS treatment for any reason
• Cardiac pacemaker
• The risk of seizure with any reasons
• Pregnancy
• High risk of suicide
• Intracranial implant and other ferromagnetic materials close to the head

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: collaborator

University of Tehran

OTHER

Sponsor Role: lead

Responsible Party

reza kazemi

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Reza Kazemi, PhD

Role: PRINCIPAL_INVESTIGATOR

Atieh Clinical Neuroscience center

Locations

Atieh Clinical Neuroscience Center (ACNC)

Tehran, , Iran

Countries

Iran

References

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.

Reference Type: RESULT

PMID: 36055535 (View on PubMed)

Other Identifiers

4748

Identifier Type: -

Identifier Source: org_study_id