Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT01431001
NCT01431001CompletedNot Applicable

Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study

Cervel Neurotech, Inc.8 sites in 2 countries40 target enrollmentStarted: October 1, 2011Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
40
Locations
8
Primary Endpoint
Remission from depression
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

Remission from depression

Time Frame: baseline through 4 weeks post

Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post

Secondary Outcomes

  • Safety and tolerability of rTMS(baseline through 4 weeks post)

Investigators

Sponsor
Cervel Neurotech, Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (8)

Loading locations...

Similar Trials

Unknown
Phase 2
Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's DiseaseApathyAlzheimer's Disease
NCT01885806Federal University of Minas Gerais40
Recruiting
Phase 2
Treatment to Promote Self-regulation in Children With Autism Spectrum DisorderSelf-Regulation, EmotionAutism Spectrum Disorder
NCT05235919Holland Bloorview Kids Rehabilitation Hospital50
Completed
Phase 2
Brain Stimulation for Traumatic Brain InjuryTraumatic Brain InjuryDiffuse Axonal Injury
NCT02167971University of Sao Paulo30
Terminated
Not Applicable
The Efficacy & Safety of rTMS for Upper-limb Motor Function Recovery in Subcortical and Brainstem StrokeHemiplegiaSubcortical InfarctionStroke
NCT05535504Seoul National University Bundang Hospital60
Completed
Not Applicable
Repeated Transcranial Magnetic Stimulation Relieves Maternal Care ImpairmentMaternal Care PatternsRepetitive Transcranial Magnetic Stimulation (rTMS)Functional Magnetic Resonance Imaging
NCT06743724The First Affiliated Hospital of Soochow University45