|- candidate number||24365|
|- NTR Number||NTR5862|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-mei-2016|
|- Secondary IDs||NL56137.041.16 ABR protocol number|
|- Public Title||Stimulation Therapy in Miltary Veterans|
|- Scientific Title||Stimulation Therapy in Miltary Veterans|
|- hypothesis||A tDCS intervention in veterans with anxiety and/or aggression problems increases the effects of an inhibitory control training|
|- Healt Condition(s) or Problem(s) studied||Anxiety, Trauma , Aggression, Therapy|
|- Inclusion criteria||- Veteran of the Dutch Defense organization|
- Age 18 – 50
- 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)|
- Treatment for alcohol or drug dependence
- Severe psychiatric or neurological disorders, e.g., Parkinson’s disease.
- Serious head trauma or brain surgery
- Large or ferromagnetic metal parts in the head (except for a dental wire)
- Implanted cardiac pacemaker or neurostimulator
- 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)
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||15-mei-2016|
|- planned closingdate||15-mei-2018|
|- Target number of participants||96|
|- Interventions||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. Subjects receive 5 sessions of either real or sham tDCS + inhibitory control training.|
|- Primary outcome||Inhibitory control performance (stop signal reaction time, SSRT) on the stop signal task at the 5th training session.|
|- Secondary outcome||Short-term: |
- Pre- to post changes on symptomatology (PTSD, anxiety, aggression/anger, depression, impulsivity and therapy progress)
- Pre- to post changes on inhibitory control (emotional Go/NoGo task, implicit association test).
- Post-intervention attentional threat avoidance (dot-probe task)
- Changes in symptomatology on 3-month and 12-month follow-up.
|- Timepoints||T1. Pre-assessment: DSM Axis-I comorbodity, self-report symptomatology, inhibitory control performance.
Intervention. 5 training sessions with stop-signal task (SST).|
T2. Post-assessment: self-report symptomatology, inhibitory control performance.
T3. follow-up after 3 months: self-report symptomatology.
T4. follow-up 12 months: self-report symptomatology
|- Trial web site||-|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. T.E. Gladwin|
|- CONTACT for SCIENTIFIC QUERIES||Dr. T.E. Gladwin|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|- Brief 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. Amounting evidence shows positive effects of tDCS to the prefrontal cortex on psychiatric disorders like depression and drug- or alcohol dependence. Moreover, it has been shown that inhibitory control can be enhanced by applying transcranial direct current stimulation (tDCS) to the right inferior frontal gyrus.
The goal of the study is to test within an anxiety and aggression patient sample the effect of a tDCS intervention in combination with an inhibitory control training on inhibitory control performance, attention bias in response to threat and anxiety and aggression symptoms. Subjects undergo a 5-session tDCS intervention that takes place in a period of usual treatment. The tDCS (1.25 mA, 20 min.) electrodes are placed over the right inferior frontal gyrus (anodal) and over the left eyebrow (cathodal). Before and after the intervention inhibitory control performance an symptomatology are measured. Long-term measures of symptomatology are taken at 3 months and 12 months follow-ups.|
|- Main changes (audit trail)|
|- RECORD||18-mei-2016 - 2-jul-2016|