Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression

Cervel Neurotech

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01431001

NS-CPS-TRMD-1

Details and patient eligibility

About

The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Major depressive disorder (MDD)
• Mild to moderate level of resistance or intolerance to antidepressant treatment in the current episode.
• Will not become pregnant during study.

Exclusion criteria

• Seizure disorder.
• History of brain injury or active CNS disease.
• Metal implants on or in brain, spinal cord, ear, eye or heart.
• Current use of proconvulsant medications (e.g., bupropion).
• Other significant psychiatric disorder.
• Substance use disorder (not including caffeine or nicotine).
• 7 or more failed treatment attempts for depression in one's lifetime.
• Have failed to clinically remit to an adequate trial of ECT or TMS.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Coil Configuration A

Experimental group

Description:

Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

Treatment:

Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

Coil Configuration B

Experimental group

Description:

Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)

Treatment:

Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)