1. To determine demographic, clinical, and brain morphological and functional predictors for IST, and; 2. To examine their associations with the level of increase of seizure threshold (*ST) during the ECT course, as measured at every sixth ECT-…
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
a. Level of IST and level of seizure threshold at every 6th ECT-session;
b. Thickness of the skull and scalp; volume and amount of white matter
hyperintensities (WMH); cortical thickness; volumes of gray and white matter;
and volume of cerebrospinal fluid (CSF) using magnetic resonance imaging (MRI);
c. Resting state functional connectivity using blood oxygen level-dependent
signals (BOLD) on functional MRI (fMRI) of specific areas;
d. Amount of axonal density (*fractional anisotropy*) as measured with
Diffusion Tensor Imaging (DTI) of specific areas.
Secondary outcome
The association between IST, *ST, demographic, clinical, and brain
morphological and functional predictors and effectiveness of ECT.
Background summary
Electroconvulsive therapy (ECT) is an effective and safe treatment for
depression, as well as for other severe psychiatric conditions. In ECT, the
electrical stimulus must exceed the initial seizure threshold (IST) to elicit a
generalized seizure. Clinically it is known that seizure thresholds vary
substantially among patients and seizure thresholds intend to raise during the
treatment course. Several hypothesis are described to explain the variety of
IST levels in patients, but most hypotheses on morphologically, functionally
and clinically influencing factors were neither examined extensively nor
studied prospectively for this purpose.
Study objective
1. To determine demographic, clinical, and brain morphological and functional
predictors for IST, and;
2. To examine their associations with the level of increase of seizure
threshold (*ST) during the ECT course, as measured at every sixth ECT-session.
Study design
Prospective, observational, cohort study.
Study burden and risks
Every subject undergoes standard procedures (ECT, dose-titration, MRI) and the
extra burden for the patient for this study are within reasonable limits (i.e.
10-15 minutes extra time in the MRI-scanner). No additional risks for the
patients health are expected with this study. If coincidentally pathological
findings will be present, further treatment strategies will be discussed by the
consulted neurologist and treating psychiatrist.
This research may result in non-invasive measurement of IST in advance, and
therefore future patients may benefit, as the first treatment session will not
has to be used for dose-titration and ECT will start immediately with a
therapeutic electrical dose.
Postbus 9555
6800 TA ARNHEM
NL
Postbus 9555
6800 TA ARNHEM
NL
Listed location countries
Age
Inclusion criteria
The sample of subjects contains all patients referred for ECT to the Alysis Zorggroep, location Rijnstate Hospital, Arnhem, the Netherlands
Exclusion criteria
a. age < 18 years;
b. no informed consent;
c. contraindications for dose-titration (e.g. life threatening condition of the patient, severe cardiovascular comorbidity);
d. contraindication for undergoing MRI (e.g. metals in the body, claustrophobic reactions, patient cannot lay still).
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 | NL24697.091.09 |