Major Depressive Disorder (MDD)NCT01683019
Feasibility Study to Test Clinical Efficacy of Low Energy AC Magnetic Field to Treat Major Depression
A study testing NeoSync EEG Synchronization Therapy in people with Major Depressive Disorder (MDD), run by Wave Neuroscience at 2 sites in 2 countries.
Trial summary
This feasibility study investigates effects of EEG-based low frequency, low emission magnetic cortical stimulation in comparison to a sham treatment in subjects with moderate to severe depressive disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Depressive Disorder (MDD)
- What is being tested?
- NeoSync EEG Synchronization Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2008to Dec 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- Diagnosis of MDD with HAMD-17 greater than or equal to 17
- On a stable dose of existing medication or no medication for 1 month or longer prior to the study
Who cannot join
- Diagnosed with another primary Axis I illness
- Recent history of or current substance abuse
- Clinically significant medical illness, including any thyroid disorders
- Known pregnancy and/or lactation, or intent to become pregnant during the study
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A MULTICENTER, RANDOMIZED, BLINDED, SHAM CONTROLLED, PARALLEL GROUP TRIAL TO TEST CLINICAL EFFICACY OF LOW FREQUENCY AC MAGNETIC FIELD INDUCED EEG SYNCHRONIZATION IN MAJOR DEPRESSION
This feasibility study investigates effects of EEG-based low frequency, low emission magnetic cortical stimulation in comparison to a sham treatment in subjects with moderate to severe depressive disorder.
Read the detailed description
Major Depressive Disorder (MDD) is associated with functional impairment and disability, and results in a significant burden on the affected individual, his or her family, and society in general. Psychopharmacological therapy has been shown to be effective, but may be accompanied by significant side effects. The investigators propose an alternative model, based on the relationship between symptoms, brain metabolism, and neural activity as recorded with electroencephalography (EEG). Subjects with MDD often have decreased brain metabolism, accompanied by increased EEG activity in the alpha band. The investigators hypothesis is that a gentle, non-significant risk, sinusoidal magnetic field above the subject's scalp, which oscillates at precisely his or her Intrinsic Alpha Frequency (IAF) can take advantage of this relationship to reduce symptoms without the significant side effects associated with pharmaceuticals. The investigators propose a 4-week, sham controlled, randomized, double-blind multi-center feasibility study to determine the efficacy of synchronized low energy magnetic fields delivered at the subject's IAF to treat MDD. Treatment will be given concomitant to the subject's existing medication, and will occur 5 days per week at the clinical site. Target enrollment is 45 adult subjects diagnosed with MDD.
- Conditions
- Major Depressive Disorder (MDD)
- Being tested
- NeoSync EEG Synchronization Therapy, Sham NeoSync EEG Synchronization Therapy
- Keywords
- Depression, magnetic field, alpha frequency, EEG, NeoSync EEG Synchronization Therapy
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeoSync EEG Synchronization TherapyDevice
Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.
Sham NeoSync EEG Synchronization TherapyDevice
A device that looks and sounds similar to the active treatment, but no magnetic field is generated.
| Study group | Role | What they receive |
|---|---|---|
| Active Fixed Alpha Frequency Magnetic Stimulation | Active comparator | Sinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF). Receives: Device: NeoSync EEG Synchronization Therapy |
| Active Random Frequency Magnetic Stimulation | Active comparator | Magnetic field hops to random frequencies in the alpha band (8-13Hz), once per second. Receives: Device: NeoSync EEG Synchronization Therapy |
| Inactive Sham Treatment | Sham comparator | Generate sound similar to active treatment, except that no magnetic field is generated. Receives: Device: Sham NeoSync EEG Synchronization Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.
Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment.
The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression.
Measured: Assessed at baseline and the end of Week 4 of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startJun 2008
- Primary completionNov 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Major Depressive Disorder (MDD)Studies 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wave Neuroscience
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01683019
- Sponsor's protocol ID
- NST#002
- Status last verified
- Dec 2018
- First submitted
- 4 Sep 2012
- Last updated
- 7 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
Publications
Jin Y, Phillips B. A pilot study of the use of EEG-based synchronized Transcranial Magnetic Stimulation (sTMS) for treatment of Major Depression. BMC Psychiatry. 2014 Jan 18;14:13. doi: 10.1186/1471-244X-14-13.
PubMed 24438321
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A MULTICENTER, RANDOMIZED, BLINDED, SHAM CONTROLLED, PARALLEL GROUP TRIAL TO TEST CLINICAL EFFICACY OF LOW FREQUENCY AC MAGNETIC FIELD INDUCED EEG SYNCHRONIZATION IN MAJOR DEPRESSION
- ClinicalTrials.gov ID
- NCT01683019
- Acronym / sponsor ID
- NST#002
- Conditions
- Major Depressive Disorder (MDD)
- Keywords
- Depression, magnetic field, alpha frequency, EEG, NeoSync EEG Synchronization Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Wave NeuroscienceIndustry (pharma, biotech, devices)
- Study start
- Jun 2008
- Primary completion
- Nov 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Posted 5 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility study investigates effects of EEG-based low frequency, low emission magnetic cortical stimulation in comparison to a sham treatment in subjects with moderate to severe depressive disorder.
Detailed description
Major Depressive Disorder (MDD) is associated with functional impairment and disability, and results in a significant burden on the affected individual, his or her family, and society in general. Psychopharmacological therapy has been shown to be effective, but may be accompanied by significant side effects. The investigators propose an alternative model, based on the relationship between symptoms, brain metabolism, and neural activity as recorded with electroencephalography (EEG). Subjects with MDD often have decreased brain metabolism, accompanied by increased EEG activity in the alpha band. The investigators hypothesis is that a gentle, non-significant risk, sinusoidal magnetic field above the subject's scalp, which oscillates at precisely his or her Intrinsic Alpha Frequency (IAF) can take advantage of this relationship to reduce symptoms without the significant side effects associated with pharmaceuticals. The investigators propose a 4-week, sham controlled, randomized, double-blind multi-center feasibility study to determine the efficacy of synchronized low energy magnetic fields delivered at the subject's IAF to treat MDD. Treatment will be given concomitant to the subject's existing medication, and will occur 5 days per week at the clinical site. Target enrollment is 45 adult subjects diagnosed with MDD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Active Fixed Alpha Frequency Magnetic Stimulation | Active comparator | Device: NeoSync EEG Synchronization TherapySinusoidal magnetic field set to the subject's intrinsic alpha frequency (IAF). |
| Active Random Frequency Magnetic Stimulation | Active comparator | Device: NeoSync EEG Synchronization TherapyMagnetic field hops to random frequencies in the alpha band (8-13Hz), once per second. |
| Inactive Sham Treatment | Sham comparator | Device: Sham NeoSync EEG Synchronization TherapyGenerate sound similar to active treatment, except that no magnetic field is generated. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years of age or older
- Diagnosis of MDD with HAMD-17 greater than or equal to 17
- On a stable dose of existing medication or no medication for 1 month or longer prior to the study
Key exclusion criteria (4 listed)
- Diagnosed with another primary Axis I illness
- Recent history of or current substance abuse
- Clinically significant medical illness, including any thyroid disorders
- Known pregnancy and/or lactation, or intent to become pregnant during the study
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 |
|---|---|---|
| NeoSync EEG Synchronization TherapyGenerate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks. | Device | Active Fixed Alpha Frequency Magnetic Stimulation, Active Random Frequency Magnetic Stimulation |
| Sham NeoSync EEG Synchronization TherapyA device that looks and sounds similar to the active treatment, but no magnetic field is generated. | Device | Inactive Sham Treatment |
Primary outcome
Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment.
Time frame: Assessed at baseline and the end of Week 4 of treatment.
Outcome measured using the Hamilton Depression Rating Scale (HAMD-17) and calculated as percent change in severity score from baseline until the end of the 4th week of treatment. The HAMD-17 scale ranges between 0-54, with higher numbers indicating more severe symptoms. 0-7 is generally accepted to be within the normal range (or in clinical remission), while a score of 20 or higher indicates moderate to severe depression.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24438321Jin Y, Phillips B. A pilot study of the use of EEG-based synchronized Transcranial Magnetic Stimulation (sTMS) for treatment of Major Depression. BMC Psychiatry. 2014 Jan 18;14:13. doi: 10.1186/1471-244X-14-13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeoSync EEG Synchronization Therapy in people with Major Depressive Disorder (MDD), run by Wave Neuroscience at 2 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 4 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 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, China. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 5 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percent Change in Hamilton Depression Rating Scale (HAMD-17) at Baseline and the End of Week 4 of Treatment. (time frame: Assessed at baseline and the end of Week 4 of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01683019, which also lists 1 linked publication.
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 7 Dec 2018.