The primary objective is to determine whether there is a difference in intracortical inhibition and cortical plasticity between MDD patients and unaffected controls.
ID
Source
Brief title
Condition
- Mood disorders and disturbances NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Intracortical inhibition as measured with the SICI paradigm: the difference
in MEP amplitude induced by paired pulse stimulations with a conditioning pulse
of 80% RMT and unconditioned single TMS pulses at SI1mV.
- Intracortical inhibition as measured with the CSP: the duration of the CSP
after a single supratheshold TMS pulse applied at a tonically preactivated FDI
muscle, averaged over 20 pulses.
- Neuronal plasticity as measured with the iTBS: mean MEP amplitude at the FDI
muscle before iTBS (pre-iTBS), and at 5 time points after the iTBS procedure (0
min; 5 min; 10 min; 15 min; 20 min). The iTBS effect is determined as the mean
MEP amplitude of the time points after iTBS relative to baseline values.
Secondary outcome
- Difference in HAM-D score at baseline and after 6 weeks of treatment as usual
within the MDD inpatients
Background summary
The neurophysiology of MDD is complex and largely unknown. The neurotransmitter
systems serotonin, norepinephrine and dopamine are thought to play a role in
classic pathophysiologic models of MDD. However, previous clinical and
preclinical studies showed evidence that the Gamma-AminoButyric Acid (GABA)
neurotransmitter system also is involved in the pathophysiology of MDD.
GABAergic interneurons induce intracortical inhibition, which affects synaptic
strengthening during long-term potentiation. To further study the role of
GABAergic intracortical inhibition and cortical plasticity in the cognitive and
behavioral deficits in severely depressed inpatients, a non-invasive method to
study these neurophysiological processes is needed. Transcranial Magnetic
Stimulation (TMS) has proven to be a very useful tool in this respect. We will
use TMS to study cortical inhibition with the Short Interval Cortical
Inhibition (SICI) paradigm and measuring the Cortical Silent Period (CSP).
Additionally, we will use intermittent Theta-Burst Stimulation (iTBS) as TMS
paradigm to induce cortical plasticity by administering intermittent bursts of
pulses for two seconds long with an interburst interval of 10 seconds, and
subsequently study aftereffects during a period of 20 minutes.
Study objective
The primary objective is to determine whether there is a difference in
intracortical inhibition and cortical plasticity between MDD patients and
unaffected controls.
Study design
Observational case-control study
Study burden and risks
The total time investment for participants will be ±3 hours, which consists for
the unaffected controls of a telephone call for eligibility screening (±30 min)
and a single visit to the department of Psychiatry of the Erasmus MC for the
TMS measurement. For inpatients with MDD, questionnaires regarding screening
will be filled in on the ward. The TMS lab is within the department of
Psychiatry and easily accessible for the patients. TMS stimulations can induce
a transient headache, and local pain or neck pain, which may vary from subject
to subject. This is depending on individual susceptibility, and intensity and
frequency of stimulation. However, these effects are negligible in terms of
safety concerns (Rossi et al., 2009). The measurement will be aborted in case a
participant considers the measurement painful. Additionally, the TMS protocol
could theoretically induce epileptic seizures due to the high frequent
stimulations during iTBS. Epilepsy was never observed as a result of iTBS in
previous studies, only as a result of repetitive TMS and continuous TBS (Hong
et al., 2015; Oberman et al., 2011). Nevertheless, due to the high similarity
with these two TMS protocols, iTBS should be applied with caution. We will,
therefore, screen participants for epilepsy risk factors using a standardized
questionnaire in order to minimize the risk of an iTBS-induced epileptic
seizure. Participants will be reimbursed with ¤50 and compensated for travel
and parking expenses. There are no therapeutic benefits from this study.
's Gravendijkwal 230
Rotterdam 3015 CE
NL
's Gravendijkwal 230
Rotterdam 3015 CE
NL
Listed location countries
Age
Inclusion criteria
Unaffected controls:
Age: 18-85 years
Informed consent
Good health
Beck Depression Inventory * 9;Inpatients with MDD:
Age: 18-85 years
Informed consent
MDD confirmed diagnosis
Initial HAM-D score * 18
Being free of psychotropic drugs for 1 week
Exclusion criteria
Pregnancy
Use of psycho-active agents
Neurological illness influencing the motor system
Not passing the Rossi safety check-list (Rossi et al., 2009)
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 | NL60197.078.16 |