None listed
Conditions
Brief summary
Deep Transcranial magnetic stimulation (dTMS) is a form of repetitive transcranial magnetic stimulation (rTMS) which has been established as a safe, effective and well-tolerated treatment for depression, especially in patients who do not respond to initial antidepressant medication treatment. Although dTMS, and other forms of rTMS, are effective treatments, only about 50% of patients get a substantial clinical response and for some this can take a considerable period of time. Over recent years we have conducted extensive research developing methods to enhance treatment response to forms of rTMS including exploring whether improving the targeting of treatment into relevant brain areas can improve clinical outcomes. dTMS involves the application of repetitive pulses using a coil that has a deeper and wider area of stimulation of the brain. There are a number of dTMS coils commercially available which allow for stimulation of different areas of the brain. For example, H1 coil is typically used to stimulate a relatively large area of the lateral prefrontal cortex. In contrast, the H7 coil is applied to stimulate medial prefrontal regions. Evidence suggests that meaningful therapeutic benefits in patients with depression can be achieved with stimulation of both lateral and medial prefrontal cortex although there may be differences in the clinical characteristics of patients who respond to treatment at these two locations. The aim of the current research is to explore whether clinical outcomes may be improved using an approach which combines stimulation of these two sites. Specifically, we will compare treatment at the lateral prefrontal cortex with the H1 coil alone (current standard treatment) to a dual approach stimulating both lateral prefrontal cortex with the H1 coil and medial prefrontal cortex with the H7 coil.
Interventions
To aim of this study is to investigate the efficacy of a novel dual target deep transcranial alternating current stimulation (dTMS) treatment approach for major depressive disorder. To do this, we conduct a randomized parallel design study with blinded assessment of treatment outcomes across three treatment groups:
1. patients who receive standard lateral stimulation with the H1 coil and sham stimulation
2. patients who receive one application of stimulation with the H1 coil at the lateral pr
To aim of this study is to investigate the efficacy of a novel dual target deep transcranial alternating current stimulation (dTMS) treatment approach for major depressive disorder. To do this, we conduct a randomized parallel design study with blinded assessment of treatment outcomes across three treatment groups: 1. patients who receive standard lateral stimulation with the H1 coil and sham stimulation 2. patients who receive one application of stimulation with the H1 coil at the lateral prefrontal stimulation site and then a second application of stimulation at the same site, using the same coil. 3. patients who receive stimulation with both the H1 coil applied to lateral prefrontal cortex and the H7 coil applied to medial prefrontal cortex. H1 and H7 coils will look the same. However, the placement of magnets differ between the two types of coils. All patients will receive 35 sessions of one of two forms of dTMS: standard or dual target. Each treatment course will consist of 30 sessions, 5 days per week with an additional five sessions applied after this - three in the seventh week and two in the eighth week. Treatment sessions will involve the application of intermittent theta burst stimulation (iTBS) at 120% of the RMT as assessed by standard visual means. Sham stimulation will be applied at 25% of RMT. All iTBS will be applied in triplet burst of 3 pulses at 50Hz repeated at 5Hz in 2 second trains with an eight second inter-train interval (total of 600 pulses). All treatments will occur at a Monarch Mental Health Group clinic, administered by a TMS practitioner. For treatment arm 1 and 3 there will be no break between stimulation at sites and for treatment arm 2, there will be a 5 minute break between stimulations. The overall session will run for approximately 20 minutes. Clinical outcomes will be performed at baseline, 1 week, 2 weeks, 3 weeks, 4 weeks, end of treatment and at 1, 3 and 6 month follow up. These include an interview with trained research staff via video conference call, and self report questionnaires conducted via electronic links. Participants will be provided with a personalised schedule for their time in the study and the treatment and study teams will keep record of the number of treatments and days they attend.
Sponsors
Australian National University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
- Diagnosis of major depressive episode (MDE), in accordance with the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5), in the context of unipolar major depressive disorder or bipolar affective disorder. - 18-85 years of age. - Treatment resistant depression at Stage II of the Thase and Rush classification. - Hamilton Depression Rating Scale (HAMD) score of >17 (moderate – severe depression). - No increase or initiation of new antidepressant therapy in the four weeks prior to screening. - Demonstrated capacity to give informed consent.
Exclusion criteria
- Inability to provide informed consent - Medically unstable patients - Concomitant neurological disorder or a history of a seizure disorder. - Patients who are pregnant or breastfeeding. - Active suicidal intent - Any psychotic disorder or current active psychotic symptoms -Patients who have intracranial implants deemed unsafe for TMS. - Significant difficulties understanding or communicating in English
Outcome results
None listed