To test within an anxiety and aggression patient sample the effect of a tDCS intervention on (i) task-specific inhibitory control, and (ii) threat and implicit inhibitory control, attention bias and anxiety and aggression symptom reduction in a…
ID
Source
Brief title
Condition
- Anxiety disorders and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is the pre-to post-intervention change in inhibitory
control on the training task (stop-signal task).
Secondary outcome
Second, we aim to test the pre-to post-intervention changes in symptoms related
to anxiety and aggression, threat-related (emotional Go/No-Go task) and
implicit inhibitory control (implicit association task). Additionally we look
at post-intervention attentional threat avoidance (dot-probe task). Finally, we
assess symptom reduction at 3 and 12 months follow-up.
Background summary
A substantial part of patients with trauma-related anxiety or aggression
disorders does not sufficiently recover after psychotherapy. Recovery is likely
impaired by difficulties with inhibitory control over (emotional) impulses. It
has been shown that inhibitory control can be enhanced by applying transcranial
direct current stimulation (tDCS) to the prefrontal cortex. Moreover, amounting
evidence shows positive effects of tDCS to the prefrontal cortex on depression
and craving symptoms. These findings suggest a potential therapeutic or
treatment facilitating effect of tDCS for patients with anxiety or aggression
problems.
Study objective
To test within an anxiety and aggression patient sample the effect of a tDCS
intervention on (i) task-specific inhibitory control, and (ii) threat and
implicit inhibitory control, attention bias and anxiety and aggression symptom
reduction in a period of usual treatment.
Study design
This is a double-blind placebo-controlled intervention study with an
experimental group (active tDCS) and a control group (sham tDCS). Subjects
undergo a 5-session intervention. Pre- and post-intervention assessments and
follow-ups provide insight in effects over time on inhibitory control (tasks)
and PTSD, anxiety, aggression and mood symptoms (questionnaires).
Intervention
TDCS (1.25 mA, 20 min.) increases neural excitability under the anodal
electrode (here: attached to the scalp over the right inferior frontal gyrus,
rIFG) and decreases neural excitability under the cathodal electrode (here:
attached over the left eyebrow). This increases activation of the rIFG, a brain
region strongly involved in inhibitory control. Subjects simultaneously receive
tDCS and perform an inhibitory control (stop-signal) task, to facilitate the
effects of tDCS.
Study burden and risks
The total number of separate assessment time points is 10. Because pre- and
post-assessments and follow-ups are completed online, each subject has 6 visits
in total (1 intake, 5 tDCS sessions). Subjects continue with usual treatment
during the study period. The application of tDCS in this study is considered
safe. Common side-effects of tDCS are minor (e.g. a light itching sensation or
skin irritation under the electrode).
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Dutch military personnel
- Age 18 - 60 years
- Presence of problems with aggression regulation according to criteria as described in (Coccaro, 2012) or any anxiety disorder according to DSM-IV criteria except for obsessive-compulsive disorder (OCD)
- Receive treatment for above-mentioned symptoms
- Provide written informed consent
Exclusion criteria
- Predominant major depressive disorder (MDD)
- Alcohol or drug dependence
- Severe psychiatric or neurological disorders, e.g., Parkinson*s disease.
- Serious head trauma or brain surgery (N.B. TBI without brain damage or skull damage is not a reason for exclusion)
- Large or ferromagnetic metal parts in the head (except for a dental wire)
- Implanted cardiac pacemaker or neurostimulator
- Pregnancy
- Concurrent or recent (within previous month) participation in a neuromodulation / neurostimulation (e.g., tDCS, TMS) experiment.
- Skin damage or diseases at intended electrode sites (tDCS)
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
In other registers
| Register | ID |
|---|---|
| CCMO | NL56137.041.16 |
| OMON | NL-OMON27064 |