Clinical Trials

TO ENROLL IN A CLINICAL TRIAL
or find out more information,
please call the clinical coordinator:

Ms. Lis Bernhardt
lis.bern@duke.edu
t: (919) 681-0603
f: (919) 681-8744



Transcranial Magnetic Stimulation (TMS)

TMS uses magnetic fields that are applied to the head with a compact and portable electromagnetic coil. These magnetic fields are turned on and off very rapidly. This fluctuation in the field induces a small electrical stimulation in the brain that stimulates the neurons and causes them to fire. This stimulation releases neurotransmitters in the brain, and modulates the firing rate of the circuit. Depending on the frequency of stimulation, TMS can either excite or inhibit brain function. TMS can be focused to small regions of the brain (0.5 cm), allowing us to target specific brain structures. Over 30 published controlled trials already show efficacy of TMS in depression, and TMS is already approved in the United States and Canada. A significant number also show promise in schizophrenia, neurorehabilition and recovery of function following stroke, and other conditions.

TMS is now clinically available with the FDA approved system. CNL also conducts clinical trials using various investigational TMS devices.

Active and currently recruiting clinical trials using TMS at Duke:
Synchronized Transcranial Magnetic Stimulation (sTMS) in Major Depressive Disorder (NEST-MDD)
Click here for the patient brochure on this new investigational device.

A Prospective, Double Blind, Randomized, Controlled Trial to Evaluate the Safety and Efficacy of the H1-Coil Deep Transcranial Magnetic Stimulation (TMS) in Conjunction With Mood Stabilizers in Subjects With Bipolar Depression

Past clinical trials using TMS (not currently recruiting) at Duke:
Evaluation of the Brainsway Deep Transcranial Magnetic Stimulation (TMS) H-Coil in the Treatment of Major Depression Disorder

TMS is also used as a tool in neuroscience to investigate brain function in the Center's Non-invasive Neuromodulatory Neuroscience Lab (N3 Lab).  The Center's Brain Stimulation Engineering Lab (BSEL) develops new TMS devices and paradigms to further the field of brain stimulation.



Electroconvulsive Therapy (ECT)

ECT has been modernized substantially since it was first introduced some 70 years ago. ECT remains the most effective and rapidly acting treatment for severe medication resistant depression and other disorders. While ECT is the “gold standard,” current research is pushing the envelope to create a new standard, one that does not carry the same side effect burden as ECT. ECT has already come a long way, but the ECT of the future may be very different from the ECT of today. It will likely be performed more focally and precisely. We may use entirely new ways of inducing the seizure, with different types of electricity or with magnetic fields (see MST below).

Recent research is innovating safer forms of ECT (dose titrated to the seizure threshold, right unilateral, ultrabrief pulse, focal induction). The value of these innovations will need to be established with controlled trials, and then these innovations will need to be implemented into clinical practice through national guidelines and educational initiatives.

Active and currently recruiting clinical trials using ECT at Duke:
Prolonging Remission in Depressed Elderly



Magnetic Seizure Therapy (MST)

MST was developed in the Columbia University/New York State Psychiatric Institute. This work is motivated by the conviction that people with severe depression should not have to accept memory loss as a necessary consequence of effective treatment. MST uses TMS (see above) to perform a more focused form of convulsive therapy. ECT is highly effective but carries a risk of serious side effects such as amnesia or memory loss. MST takes advantage of the fact that magnetic fields can be focused. MST targets the stimulation in the prefrontal cortex (a region of the brain thought to be critical for antidepressant response), and limits the degree to which it spreads to the hippocampus (a region of the brain important for memory). MST holds the promise of retaining the efficacy of ECT, but without its side effect burden. If MST is proven effective, it could represent a breakthrough in the way that our most severe psychiatric disorders are treated.

Past clinical trials using MST (not currently recruiting) at Duke:
Magnetic Seizure Therapy (MST) for Severe Mood Disorder

Unfortunately, we do not have any clinical trials recruiting for patients. A two-center trial comparing the efficacy of MST versus ECT will be completed in the summer of 2012.



Transcranial Direct Current Stimulation (tDCS)

tDCS uses very weak electrical fields applied to the scalp to polarize the brain. Polarization changes the firing rate of neurons. Depending on the direction of current flow, this polarization can either inhibit or facilitate function. Recent work suggests that tDCS may have promise in depression, and work on its potential is underway.

Clinical trials using tDCS at Duke:
There will be a clinical trial using tDCS for unipolar and bipolar depression in the near future.






Deep Brain Stimulation (DBS)

Small electrodes are implanted into the brain to stimulate regions that are too deep to reach by stimulating the scalp. DBS is already approved for the treatment of Parkinson’s disease, and is under study for the treatment of severe and treatment resistant OCD and major depression. Recently published work supported antidepressant efficacy of DBS. More controlled work in larger sample sizes will be important to establishing the potential clinical role of DBS, but early results are quite encouraging.

Clinical trails using DBS at Duke:
There will be a clinical trial using DBS for unipolar depression in the near future.




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Rosa Jou-Zhang,
Jul 25, 2012, 11:49 AM
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