Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2025-12-26 @ 1:26 AM
Study NCT ID:
NCT01370733
Status:
COMPLETED
Last Update Posted:
2015-10-26
First Post:
2011-06-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder
Sponsor:
Wave Neuroscience
Organization:
Study Overview
Official Title:
Evaluation of Low Emission NeoSync EEG Synchronized TMS Technology for the Treatment of Major Depressive Disorder: A Multicenter, Randomized, Double-Blind, Sham-Controlled, Trial
Status:
COMPLETED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEST-MDD
Brief Summary:
This study is designed to evaluate the safety and efficacy of synchronized transcranial magnetic stimulation (sTMS) using the NeoSync EEG Synchronized TMS device (NEST) in subjects with Major Depressive Disorder. This is a multicenter study in which subjects will be randomized to receive treatment 5 days per week for 6 weeks. Subjects who complete 6 weeks of double-blind treatment may be eligible to receive up to four weeks of open label sTMS therapy or antidepressant medications during the follow-up phase of the study. Follow-up evaluation visits will be conducted during those four weeks, with the frequency of the visits determined by the treatment choice during that timeframe.
Detailed Description:
Major Depressive Disorder (MDD) is a mental disorder associated with significant functional impairment and disability. Affected individuals present with depressed mood, loss of interest or pleasure, feelings of guilt, low self-worth, disturbed sleep or appetite, low energy, and poor concentration.
Psychopharmacological therapy as today's mainstream treatment has revolutionized the clinical management for major depressive disorders and has been shown to improve the quality of life for many patients. With that, these therapies are not effective for all patients. Results released from the Sequenced Treatment Alternatives to Relieve Depression Study (STAR\*D), conducted by the National Institute of Mental Health (NIMH), show that approximately 30% of depressed subjects respond to an SSRI in their first trial, despite adequate dosing and duration of treatment. The SSRI antidepressants do have a more favorable side effect profile than older medications, but they still may be difficult for some patients to tolerate because of gastrointestinal distress, anxiety, insomnia, and sexual dysfunction.
In addition to the psychopharmacologic treatments for depression, other therapies such as electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS) have been shown to have a therapeutic effect in MDD. ECT induces seizures electrically in anesthetized subjects. It is generally safe and effective; however the procedure can have the negative side effect of memory loss and confusion. Treatment with repetitive stimulation (rTMS) is intended to stimulate groups of cells in areas of the brain linked to MDD. While the therapy is non-invasive, it is expensive, involves a complex method for locating the point of stimulation in the brain, and has the potential for seizures.
rTMS uses magnetic pulses which causes neuronal activation of specific areas in the brain. It is generally believed that this activation causes resetting of cortical oscillators to create a therapeutic effect in MDD. The investigators hypothesize that TMS using low energy, sinusoidal magnetic fields synchronized to a patient's individual alpha frequency,(sTMS), can also affect neuronal activity leading to a reemergence of intrinsic rhythms and clinical improvement in MDD. Preliminary study results using sTMS have shown improvements in depressive symptoms with minimal side effects.
This multicenter study is designed to evaluate the safety and efficacy of sTMS in subjects with Major Depressive Disorder. Subjects will be randomized to receive treatment 5 days per week for 6 weeks. At the end of Treatment Week 6, subject will have completed the study treatments and will be offered open label sTMS therapy or alternate antidepressant treatment as clinically indicated. At minimum, subjects will be asked to return for one follow-up visit four weeks after their last double-blind treatment (Week 10) for evaluation and study completion.
Psychopharmacological therapy as today's mainstream treatment has revolutionized the clinical management for major depressive disorders and has been shown to improve the quality of life for many patients. With that, these therapies are not effective for all patients. Results released from the Sequenced Treatment Alternatives to Relieve Depression Study (STAR\*D), conducted by the National Institute of Mental Health (NIMH), show that approximately 30% of depressed subjects respond to an SSRI in their first trial, despite adequate dosing and duration of treatment. The SSRI antidepressants do have a more favorable side effect profile than older medications, but they still may be difficult for some patients to tolerate because of gastrointestinal distress, anxiety, insomnia, and sexual dysfunction.
In addition to the psychopharmacologic treatments for depression, other therapies such as electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS) have been shown to have a therapeutic effect in MDD. ECT induces seizures electrically in anesthetized subjects. It is generally safe and effective; however the procedure can have the negative side effect of memory loss and confusion. Treatment with repetitive stimulation (rTMS) is intended to stimulate groups of cells in areas of the brain linked to MDD. While the therapy is non-invasive, it is expensive, involves a complex method for locating the point of stimulation in the brain, and has the potential for seizures.
rTMS uses magnetic pulses which causes neuronal activation of specific areas in the brain. It is generally believed that this activation causes resetting of cortical oscillators to create a therapeutic effect in MDD. The investigators hypothesize that TMS using low energy, sinusoidal magnetic fields synchronized to a patient's individual alpha frequency,(sTMS), can also affect neuronal activity leading to a reemergence of intrinsic rhythms and clinical improvement in MDD. Preliminary study results using sTMS have shown improvements in depressive symptoms with minimal side effects.
This multicenter study is designed to evaluate the safety and efficacy of sTMS in subjects with Major Depressive Disorder. Subjects will be randomized to receive treatment 5 days per week for 6 weeks. At the end of Treatment Week 6, subject will have completed the study treatments and will be offered open label sTMS therapy or alternate antidepressant treatment as clinically indicated. At minimum, subjects will be asked to return for one follow-up visit four weeks after their last double-blind treatment (Week 10) for evaluation and study completion.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: