The objective of this study is to detect whether stimulation during task induced activation of brainnetworks leads to a higher efficacy of rTMS and other neurobiological changes.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Depression outcome is measured using a Hamilton Depression Rating Scale - 17
items and the
Inventory of Depressive Symptoms - self rated every 5 sessions.
Secondary outcome
1. Changes in heart frequency using electrocardiogram (ECG) before and during
stimulation
2. Changes in E/I ratio using electroencephalogram (EEG) before, during and
(directly) after stimulation.
3. Changes in functional brain connectivity using functional MRI.
Background summary
Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive form of
brain stimulation, in which a magnetic coil is placed on the scalp to modify
target brain networks. rTMS is an emerging, evidence based and safe treatment
option for major depressive disorder (MDD).
A recent study showed that when combining rTMS with cognitive behavioural
therapy (CBT) during stimulation, this has an additive effect on relieving
symptoms. One of the hypotheses behind this catalytic effect is that depressive
networks can be coupled by cognitive tasks, after which rTMS induced
neuroplasticity and its antidepressant effects may spread over networks
throughout the brain during stimulation.
In this proof-of-concept project, we will use state-of-the-art neuronavigated
brain stimulation combined with cognitive tasks, to improve rTMS efficacy and
gain better insights in depressive circuitry involved in rTMS responses.
Study objective
The objective of this study is to detect whether stimulation during task
induced activation of brainnetworks leads to a higher efficacy of rTMS and
other neurobiological changes.
Study design
Proof-of-concept, double blind, randomised, cross over design with two groups.
Group 1 receives active rTMS during the emotional Stroop task, goup 2 receives
active rTMS during the Boston Naming task
After 10 sessions of rTMS a cross-over takes place, in which the cognitive task
is switched.
Intervention
High frequency rTMS (10Hz, 4 seconds stimulation, inter train interval of 11
seconds, 75 trains) on the left dorso lateral Prefrontal Cortex (dlPFC), for 20
sessions.
Study burden and risks
The risks of this research are minimal. rTMS as applied in this trial, is a
proven effective and safe treatment modality, and applied on daily basis in the
AMC. This trial consists only of extra neurobiological measurements (fMRI, ECG,
EEG) and the addition of a cognitive task during the rTMS. The burden mainly is
a burden in time.
Meibergdreef 5
Amsterdam 1105 AZ
NL
Meibergdreef 5
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Age 18 to 65 years old;
Diagnosed with Major Depressive Disorder, current episode depressive
Indication for rTMS, as indicated by a psychiatrist
Therapy resistance defined by non-response after at least one type of
antidepressant and
one adequate psychotherapy
Exclusion criteria
Diagnosis of bipolar disorder
Current depressive episode with psychotic traits
Acute suicidality
(History of) neurological disease;
(History of) epilepsy;
Pregnancy
Abnormal hearing or (uncorrected) vision;
Current disorder in substance abuse (opiate, ketamine, LSD, (meth)amphetamine,
cocaine,
solvents, cannabis, benzodiazepines or barbiturate) or alcohol abuse;
Any known other serious somatic health problem;
Used alcohol within the last 24 hours prior to each test session;
Used recreational drugs over a period of 72 hours prior to each test session.
rTMS contraindications: ICD, pacemaker, epilepsy in a first degree relative and
intracranial metal implants, such as a cochlear implant or deep brain
stimulator..
MRI contraindications: metal implants, claustrophobia.
Design
Recruitment
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 | NL80163.018.21 |