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Psychiatry trials

Phase 1 trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Obsessive-Compulsive Disorder (OCD)

A large proportion of patients with Obsessive Compulsive Disorder (OCD) continue to have symptoms despite various medical and psychiatric treatments. For over half a century, neurosurgical strategies, using invasive thermal ablation, have been developed to help treat patients with refractory OCD.

MR-guided Focused Ultrasound (MRgFUS) offers the possibility of reaching and treating an area deep in the brain, called the anterior limb of the internal capsule (ALIC) (i.e ‘bilateral capsulotomy’) by creating lesions to precisely targeted regions. This does not require open surgical approaches. There is no radiation, incision, or need to cut into the skull. Lesions are generated in real-time under MR image guidance.

The proposed study is to evaluate the safety and efficacy of MRgFUS for patients with treatment-resistant OCD. Assessments will be made before and after MRgFUS for adverse events related to treatment, for clinical symptom relief, and quality of life.

Phase 1 of the trial will involve ten patients, ages 20-80 years old, over a one-year period who will undergo one round of focused ultrasound, and then be assessed for severity of depression and level of functioning at one month, three months, six months and 12 months.

For more information or to inquire about eligibility for the trial, please contact Sachie Sharma at harquailcentre@sunnybrook.ca.

Phase 1 trial of MR-guided Focused Ultrasound (MRgFUS) Bilateral Capsulotomy for the Treatment of Refractory Major Depression

In this North American first study, researchers are investigating the safety and effectiveness of focused ultrasound to help patients with treatment-resistant Major Depression. Despite medical and psychotherapeutic treatments, a large proportion of patients with major depression remain significantly. About 10% of people with recurrent major depression, or 1.2-1.4% of the total population, will have treatment resistant Major Depression. In Ontario alone, that represents around 160,000-190,000 people. These patients are at risk for the continued morbidity, and in some cases mortality, of untreated depression.

This study is evaluating the safety and efficacy of MRgFUS for patients with treatment-resistant Major Depression and will target and lesion the anterior limb of the internal capsule (ALIC) (i.e ‘bilateral capsulotomy’). Assessments will be made before and after MRgFUS for adverse events related to treatment, for clinical symptom relief, and quality of life.

Phase 1 of the trial will involve six patients, ages 25-80 years old, over a one-year period who will undergo one round of focused ultrasound, and then be assessed for severity of depression and level of functioning at one month, three months, six months and 12 months.

For more information or to inquire about eligibility for the trial, please contact Sachie Sharma at harquailcentre@sunnybrook.ca.

Deep Brain Stimulation (DBS) for the Treatment of Refractory Post-Traumatic Stress Disorder (PTSD): Pilot Trial

The purpose of this study is to determine the safety and feasibility of DBS in people with Post-traumatic Stress Disorder (PTSD). Current research suggests that there are similarities between the symptoms of PTSD and those of anxiety and depression. Given that DBS has shown promise in the treatment of those conditions, this trial was designed to see if it could be an effective therapy for PTSD as well.

DBS is a neurosurgical procedure that involves the administration of small amounts of electricity to disrupt abnormal activity of brain structures associated with disease symptoms. It involves inserting thin electrodes into deep brain structures and electrically stimulating them in a controllable and ultimately reversible manner. The electrodes are connected to an internal pulse generator that is implanted in the upper chest region, below the collarbone.

This trial will involve five patients, ages 18-70 years old. The length of this study for participants, from the time of enrollment, is expected to be approximately 14 months (2 months before treatment, and 12 months follow-up).

For more information or to inquire about eligibility for the trial, please contact Sachie Sharma at harquailcentre@sunnybrook.ca.

Deep Brain Stimulation (DBS) for the Treatment of Refractory Alcohol Use Disorder (AUD): Pilot Trial

Treatment refractory alcohol use disorder (AUD) is a chronic and debilitating disease associated with high morbidity. Despite advances in neuroimaging, genetics, pharmacology and psychosocial interventions in the last half century, little progress has been made in altering the natural history of the condition or its outcome. Currently, there are no brain based, targeted therapies for treatment refractory AUD.

This study will investigate surgical therapy for the treatment of refractory alcoholism. It will focus on a part of the brain known as the core of the nucleus accumbens, which plays a role in addiction. It is also an area known to be successful in managing alcohol cravings and in helping maintain abstinence.

This is a phase 1, non-blinded, non-randomized, pilot trial for safety and efficacy of Deep Brain Stimulation (DBS) for AUD.

DBS is a neurosurgical procedure that involves the administration of small amounts of electricity to disrupt abnormal activity of brain structures associated with disease symptoms. It involves inserting thin electrodes into deep brain structures and electrically stimulating them in a controllable and ultimately reversible manner. The electrodes are connected to an internal pulse generator that is implanted in the upper chest region, below the collarbone.

Five subjects will be enrolled for the one year study. The primary objective of the trial is to investigate the safety and efficacy of DBS in patients with treatment refractory AUD. This will be determined by various outcome measures that will include validated scales to assess addiction and craving behaviours.

For more information or to inquire about eligibility for the trial, please contact Sachie Sharma at harquailcentre@sunnybrook.ca.