Major Depressive DisorderNCT01431001
Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression
A study testing Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS) in people with Major Depressive Disorder, run by Cervel Neurotech, Inc. at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Oct 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
Emory University
Atlanta, Georgia, 30306
Medical University of South Carolina
Charleston, South Carolina, 29425
Rush Medical College
Chicago, Illinois, 60612
Australia1 site
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, 3004
About this study
Official title: Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study
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.
- Conditions
- Major Depressive Disorder
- Being tested
- Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)
- Keywords
- Depression, MDD, Transcranial Magnetic Stimulation, Depressive Disorder, TMS
- Medical subject headings
- Depressive Disorder, Major, Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)Device
The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device
| Study group | Role | What they receive |
|---|---|---|
| Coil Configuration A | Experimental | Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS) Receives: Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS) |
| Coil Configuration B | Experimental | Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS) Receives: Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission from depression
Changes in Hamilton Rating Scale from Depression (HRSD) measured after each block of 5 treatment sessions, 2 weeks post and 4 weeks post
Measured: baseline through 4 weeks post
Secondary outcomes (1)
Safety and tolerability of rTMS
Determined by presence and absence of adverse events recorded daily
Measured: baseline through 4 weeks post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2011 (estimated)
- Study startOct 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cervel Neurotech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- AnnaMarie Daniels, Study chair, Cervel Neurotech
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01431001
- Sponsor's protocol ID
- NS-CPS-TRMD-1
- Status last verified
- May 2014
- First submitted
- 6 Sep 2011
- Last updated
- 19 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining Effectiveness of Multi-Coil rTMS for Patients With Major Depressive Disorder: A Pilot Study
- ClinicalTrials.gov ID
- NCT01431001
- Acronym / sponsor ID
- NS-CPS-TRMD-1
- Conditions
- Major Depressive Disorder
- Keywords
- Depression, MDD, Transcranial Magnetic Stimulation, Depressive Disorder, TMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cervel Neurotech, Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 9 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coil Configuration A | Experimental | Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS) |
| Coil Configuration B | Experimental | Device: Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device | Device | Coil Configuration A, Coil Configuration B |
Primary outcome
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
1 secondary outcome
Safety and tolerability of rTMS
Time frame: baseline through 4 weeks post
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AnnaMarie Daniels study chair
Cervel Neurotech
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS) in people with Major Depressive Disorder, run by Cervel Neurotech, Inc. at 4 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission from depression (time frame: baseline through 4 weeks post). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2014; AzTrials last refreshed its copy on 31 Oct 2026.