Department of Psychiatry
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Deep Brain Stimulation in Depressive Disorders

General information

Recurrent depression (Major DepressiveDisorder, MDD according to DSM-V criteria) is a chronic psychiatric disorder with a high percentage of resistance to standard treatment. It is a mental disorder that ranks first in terms of its prevalence in the general population (approx. 17%). The chronicity of the disease process, significant severity and a high percentage of resistance to treatment (10 to 30%) causes great discomfort and nuisance to the patient and his family, often leading to invalidation and social exclusion of the patient.
Deep Brain Stimulation (DBS) creates opportunities for real help for patients who are refractory to previous conventional therapy based on pharmacotherapy and psychotherapy. DBS is a modern and dynamically developing therapy based on current neuroscience research. Until now, in the world and in Poland (including the Department of Neurosurgery of the University Clinical Hospital in Wrocław) this technique was used primarily in the treatment of neurological diseases, primarily Parkinson's disease, as well as a number of motor dysfunctions (e.g. tremor or dystonia) . In addition, in 2017 the Chair and Clinic of Psychiatry and the Chair and Clinic of Neurosurgery at the Medical University of Wroclaw began a joint scientific project aimed at assessing the effectiveness of DBS in the treatment of obsessive compulsive disorder (OCD). We are currently constantly monitoring patients who are participants of this project and we see good treatment effects.

More and more centers in the world, mainly in the USA and Europe, use this method to treat mental disorders - it is commonly registered in the treatment of obsessive compulsive disorder. In the US in 2009, the FDA approved the DBS method for the treatment of refractory OCD. Currently, more and more centers in the world are conducting research using DBS to treat depression. Our unit plans to launch a pilot project in this area of ​​operation.

Detailed criteria for inclusion and exclusion from studies

Patients diagnosed with recurrent depressive disorder (MDD) will be enrolled after the following criteria have been met:
Expressing informed consent to undergo DBS therapy confirmed by a personal signature after receiving information on the details of the project (information contained in section 3.).
Resistance to previous treatment (lack or insufficient effect):
three treatments with appropriate antidepressant doses for at least 6 weeks - including at least one treatment with a serotonin and noradrenaline reuptake inhibitor (SNRI) or tricyclic antidepressant;
combined treatment with 2 antidepressants;
one-time adjuvant treatment with lithium or a second generation antipsychotic for at least 6 weeks;
at least one CBT course or interpersonal therapy (at least 16 therapeutic sessions);
one course of electroconvulsive therapy (min. 6 treatments) or contraindications for this treatment.
MDD diagnosis confirmed in accordance with DSM-V criteria;
a score of at least 25 points on the MADRS scale;
SOFAS score less than 50 points.
At least 5 years of MDD.
No vital indications for electroconvulsive therapy
Age from 20 to 65 years old.
IQ over 80.

Exclusion criteria

Presence of comorbid disease:
psychiatric disorders (psychotic disorders, autism, severe personality disorders, obsessive compulsive disorder, addiction to a psychoactive substance, dementia);
unstable somatic condition;
central nervous system disorders (including epilepsy, Parkinson's disease, multiple sclerosis).
The presence of contraindications for performing a neurosurgical procedure:
Blood coagulation disorders.
The presence of some symptoms associated with MDD:
auto-aggressive behavior, self-harm;
suicidal tendencies, current risk of committing suicide;
unstable and severely impaired functioning.
The presence of contraindications for magnetic resonance imaging of the brain.
Pregnancy.

Information for a project participant

The Chair and Clinic of Psychiatry in cooperation with the Chair and Clinic of Neurosurgery at the Medical University in Wroclaw are conducting a research project entitled "Deep Brain Stimulation (DBS) therapy for patients diagnosed with refractory depressive disorders." It aims to test the effectiveness and tolerability of this therapeutic method in patients with this mental disorder. The project team proposes you to participate in this study, which would involve carrying out DBS surgery for you. In foreign centers, it is widely registered in the treatment of obsessive compulsive disorder - in the USA in 2009, the FDA (Federal Food and Drug Administration) approved the DBS method in the indications for the treatment of refractory OCD. DBS Currently, more and more centers around the world are conducting research on the use of this method of treatment in patients with recurrent depressive disorder. It is characterized by high therapeutic efficacy with a low risk of perioperative complications and long-term side effects.
Qualification for surgery is carried out by a team consisting of a psychiatrist, neurosurgeon and anesthesiologist. Using strictly defined criteria, the team determines whether there are indications and possible contraindications to implement treatment with this method. Possible contraindications may be associated with other psychiatric disorders, some neurological diseases and other serious somatic burdens.
Deep Brain Stimulation is an operational procedure which task is to place an electrode in a selected place of the brain, which will be connected subcutaneously with a stimulator implanted in the subclavian area. After the procedure, the stimulator will be activated, then it will emit electric charges to the electrode located in the brain, which causes the stimulation of nerve cells only in a small area of ​​the brain, responsible for the psychopathological symptoms that are the basis of your mental discomfort. In the case of diagnosis of refractory depressive disorders, it is advisable to place electrodes in both hemispheres of the brain, which will take place during one operation.
The target (the specific location where the electrode will be placed) will be determined on the basis of preoperative magnetic resonance imaging. Thanks to the use of pre-operative imaging, the entire procedure can be performed with great precision, which avoids many complications. The operations will be performed under local or general anesthesia depending on the specific case - the decision on the type of anesthesia is made by the operator in consultation with the anesthetist.
After the operation, the position of the electrode will be checked by computed tomography imaging. The stimulator will be activated in the second week from the date of its implantation. In the postoperative period, regular monitoring of the general, neurological and mental condition is planned to determine the effectiveness of treatment. DBS is a method of fully reversible action on the brain, with virtually no neurological side effects. Rare complications of DBS surgery include intracranial bleeding (risk of about 2-3%), pacemaker infection or dysfunction (risk also within 5%).
The team of neurosurgeons from the Clinic of Neurosurgery at the Medical University in Wrocław performs DBS operations as the only one in Lower Silesia since 2008 and belongs to the group of leading functional neurosurgeons in Poland. He has performed over 50 DBS operations so far. Apart from two cases of minor intracranial bleeding, no other complications were noted in long-term observations.
The stimulator that will be implanted belongs to the group of the most modern devices of this type. It contains a built-in rechargeable battery, thanks to which the life of the device is many years. At the same time, this type of stimulator requires regular charging at home.
After starting the stimulation, the patient remains under the constant care of psychiatrists and neurosurgeons, control visits take place every 2 weeks for the first half year of treatment, then once a month, and after the first year of stimulation every two months.

Qualification for the study

Candidates to participate in the study will be pre-qualified by the doctors of the Chair and Clinic of Psychiatry after sending the documentation to the Chair and Clinic of Psychiatry (address on the website), containing:
description of previous treatment (minimum five years) prepared by a psychiatrist;
psychiatrist's declaration of compliance with the inclusion criteria and the elimination of the exclusion criteria;
signed consent for the patient to perform the procedure under the information on deep brain stimulation therapy.

Doctors from the Chair and Clinic of Psychiatry after reviewing the above documents and confirming the indications for DBS therapy will inform the patient about the date of personal application for a consultative examination at the Clinic. The decision to qualify for DBS therapy is made by the therapeutic team of the Chair and Clinic of Psychiatry in consultation with the doctors of the Chair and Department of Neurosurgery at the Medical University.