We aim to conduct a pilot study investigating feasibility of MST within our clinical setting. As an academic department, we are in the process of identifying MRI biomarkers of successful convulsion therapy, at this point thus based on ECT studies.…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary objective is to test the feasibility of MST.
Secondary outcome
Secondarily, we will descriptively describe the change of the depressive
symptom scores of HRSD-17, cognitive scores and tolerability profile of MST
patients. Additional endpoints concern changes in functional and structural
brain connectivity (as measured with MRI and EEG) networks as a function of MST
treatment to derive potential biomarkers for a future clinical trial.
Background summary
Since its development in 1938, electroconvulsive therapy (ECT) has been used as
a treatment for mood disorders including Major Depressive Disorder (MDD) and
particularly, treatment-resistant depression (TRD). During a session of ECT, an
electrical current is applied to the scalp of an anesthetized patient which
induces a seizure as it passes through the brain. Despite the remission rates
between 50-70% [1], it remains one of the least used treatments for depression.
Fewer than 1% of patients with TRD receive ECT due to a combination of fear,
stigma, and concerns about cognitive side effects, such as short-term amnesia
The search for alternative, yet comparably effective, therapeutic stimulation
techniques has led to the development of treatments like repetitive
transcranial magnetic stimulation (rTMS) and more recently, magnetic seizure
therapy (MST). MST is a more focal treatment that was developed to mimic the
therapeutic effects of ECT while minimizing the adverse side effects.
Specifically, MST involves the application of a magnetic field to produce a
seizure in the brain.
Compared to ECT, MST can produce remission rates between 30-60% and patients
receiving MST experience fewer cognitive side effects and recover more quickly
after the procedure compared to patients receiving ECT . ECT and MST differ in
the characteristics of the induced seizure, with the ECT-induced seizure
spreading to deeper subcortical structures, including the hippocampus, while
the MST-induced seizure is more confined to the cortex.
Studies thus far indicate that MST has a comparable antidepressant effect to
unilateral ECT, although the impact on cognitive functions remains unclear.
So while international studies are promising and more are underway, we also
need to critically test the usefulness in the Dutch care setting. In the Dutch
setting, we however use brief-pulse ECT and based on the clinical
characteristics described, we often seem to have patients with a higher level
of treatment resistance. This may also be related to the fact that in the Dutch
stepped care model, there is a tendency to regard ECT as a last resort therapy.
Study objective
We aim to conduct a pilot study investigating feasibility of MST within our
clinical setting. As an academic department, we are in the process of
identifying MRI biomarkers of successful convulsion therapy, at this point thus
based on ECT studies. Given that this feasibility study forms the basis for a
larger clinical trial, we will also explore the use of our structural and
functional markers in the group treated with MST.
Study design
Feasibility study whereby 10 patients will be treated with MST.
Intervention
Treatment with MST, applied at 100 Hz at 100% of the maximum device power for
8-10 seconds. Treatment will be continued until a clinical plateau is reached.
We will use MRI and EEG measurements to identify potential markers for
structural and functional changes in the brain.
Study burden and risks
All psychiatric measurements are administered routinely at our out- and
inpatient depression
unit. The (f)MRI/EEG measurements will require a maximum of 60 minutes of the
patients time at one time before, after 6 treatments and after stop treatment.
Risks associated with these measurements are negligible.
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Reinier Postlaan 10
Nijmegen 6500 HB
NL
Reinier Postlaan 10
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
Eligible participants are men and women aged 18 and above who will be referred
for treatment with ECT, have a major depressive episode in the context of MDD
based on the Structured Clinical Interview for DSM-IV-TR.
Exclusion criteria
Exclusion criteria will be a history of neurological disorders, head trauma,
contraindications to MST, current unstable or serious medical illnesses,
pregnancy or breastfeeding, history of ECT in the prior 6 months or failure to
previously respond to ECT, or MOCA score lower than 22.
More concrete contraindications with respect to the device are:
Patients having conductive or any magnetic-sensitive materials implanted in the
head or within 30cm of the treatment coil (examples: sutures, clips, coils,
magnetic dental implants or implanted insulin pumps). Patients who have an
implanted device that is activated or controlled in any way by physiological
signals (examples: pacemakers, implantable cardioverter-defibrillators [ICD*s],
vagus nerve stimulators [VNS] and wearable cardioverter-defibrillators [WCD*s],
even when removed.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL88555.091.24 |