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Vestibular stimulation has been shown to be a very effective noninvasive treatment for major depression. Bipolar disorder is a mental illness that presents cyclic sequences of depressive and euphoric states. Depressive phases of bipolar disorder are difficult to treat and usually are resistant to actual available treatments. This study investigates the effectiveness of a particular technique of vestibular stimulation in a group of 120 bipolar type I and II patients. After randomization 60 of them will receive specific vestibular stimulation (experimental group) and 60 will receive a sham vestibular stimulation.The study will conducted in Vest Brain, Centro de Estudios Neurovestibulares, in Chile.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vestibular stimulation | Experimental | Patients of this group will receive a specific vestibular stimulation technique. |
|
| Sham vestibular stimulation | Sham Comparator | This group of patients will receive sham vestibular stimulation, similar to experimental group vestibular stimulation in the range of under threshold frequencies undistinguished from real vestibular stimulation. The absence of vestibular nystagmic response confirms that the stimulus is sham. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vestibular stimulation | Device | A specific vestibular stimulation technique is applied to the experimental group |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission rates of depression. | 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of vestibular change. | 90 days | |
| Response rates of depression | 90 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ana M Soza, M.D. | Contact | +56992896736 | amsozaried@vestbrain.cl |
| Name | Affiliation | Role |
|---|---|---|
| Ana M Soza, M.D. | Vest Brain,Centro de Estudios Neurovestibulares | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vest Brain, Centro de Estudios Neurovestibulares | Recruiting | Santiago | 7640617 | Chile |
IPD will be shared with other researchers by asking for the information to Dr. Ana María Soza's email: amsozaried@vestbrain.cl
The data will be available in December 2019-March 2020 and can be asked to Dr. Ana María Soza´s email amsozaried@vestbrain.cl
The criteria to access is asking for the information to Dr. Ana María Soza´s email amsozaried@vestbrain.cl
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| Sham vestibular stimulation | Device | Sham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham. |
|