CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 50 enrolled
Drug / intervention
Deep Brain Transcranial Magnetic Stimulationdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01962350
NCT01962350N/ACompleted

Evaluation Clinical, Cognitive and Safety in the Treatment of Bipolar Depression With H1-Coil Deep Transcranial Magnetic Stimulation

University of Sao Paulo·interventional·Posted Oct 14, 2013·Updated Nov 22, 2016

In Brief

A clinical study evaluating Deep Brain Transcranial Magnetic Stimulation for Bipolar Depression. Completed, enrolled 50 participants across 1 site.

Detailed Summary

The treatment of bipolar disorders is always a challenge in daily practice. Mood stabilizers are partially effective in the treatment of depressive phase of the illness, although there are some reports relating to the antidepressant properties of these drugs. Other conventional methods (pharmacological) and non- conventional treatment are not effective or involve risks and side effects. Several studies with Transcranial Magnetic Stimulation (TMS) showed that magnetic stimulation daily over the left prefrontal cortex may improve the mood of patients. TMS is a noninvasive method of stimulating the brain. The instrument used nowadays in local research and application Clinical is a metallic coil formed in figure 8 (coil format 8). This instrument was capable of stimulating only surface areas of the brain, primarily the cerebral cortex, at depths of up to 3 inches below the scalp. From this angle, there is clearly a need for a means of producing magnetic fields which can reach deeper brain areas, such as those involved in mood disorders. TMS has little, if any effect in these brain areas. To this end, new coils, calls "H", that promote the stimulation of deep brain areas were developed in collaboration with the National Institute of Health (NIH) in the USA. This new coil - H1 that will be evaluated in this study has been tested for safety in NIH in 2003 by Dr. Abraham Zangen. Yet there are very few prospective clinical, randomized and controlled trials, on the effects of early and late in clinical-cognitive condition and safety of TMS with H1 coils in treating episodes of bipolar depression. The application of EMT with H1 coils can reach deepest regions of the brain and improve the clinical and cognitive condition of subjects with episodes of bipolar depression, and may be confirmed as a safe and virtually free of side effects. By an absence of treatment actually effective for bipolar depression, this study will show whether there are clinical and cognitive benefits of deep TMS with H1 coil in patients with bipolar depression.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBrazil
CollaboratorsBrainsway

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedOct 14, 2013
Enrollment StartFeb 1, 2014
Primary CompletionJul 1, 2016
Study CompletionNov 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.7 years ago

Interventions

Deep Brain Transcranial Magnetic Stimulationdevice

H1-Coil deep brain rTMS at cortex prefrontal.