Developmental and acquired brain injury Injury, Occupational Diseases, Poisoning Intracranial injury, unspecified
Conditions
Interventions
Participants will undergo four research phases lasting two - five weeks. During each phase a diary of aggressive episodes will be kept, a small heart rate monitor worn on the chest for 1-3 days, and s
Sponsors
Cambridge and Peterborough NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A diagnosis of an intellectual disability, autism or acquired brain injury 2. Male and female participants aged 18-55 years 3. Capacity to consent to participation in the study 4. Manifestation of at least one episode of verbal or physical aggression per week, when averaged over the preceding four weeks 5. Agreement from participants’ family and/or paid carers to support the trial
Exclusion criteria
Exclusion criteria: 1. The presence of a diagnosis of an affective or psychotic condition considered to underpin the aggressive episodes 2. The presence of current drug or alcohol dependence 3. A current diagnosis of epilepsy 4. Significant physical comorbidity that could interact with trial participation (for instance ongoing cardiac arrhythmias, active implants such as a cardiac pacemaker or a cochlear implant, wounds and diseased skin in the area of the tVNS electrodes) 5. Current or recent (previous 12 months) participation in a clinical trial of an investigational medicinal product (CTIMP) or medical device. 6. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of delivering the intervention, which will be determined as follows: 1. The number of hours for which the tVNS device was used as a proportion of the total number of hours required in the study protocol, for each participant – for the 2 weeks of sham stimulation and five weeks of active stimulation. 2. The number of daily behavioural diary entries recorded as a proportion of the total number of diary entries required in the study protocol, for each participant – for the five weeks of baseline-1, the two weeks of sham stimulation, the five weeks of active stimulation and the four weeks of baseline-2. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Heart rate variability (HRV) will be measured over three 24 hour periods during each of the second and fourth weeks of baseline-1, active and baseline-2 phases and during the second week of the sham stimulation phase. On each of these occasions it will be measured over a 15-minute rest period at the start of the 24 hour recording and as an average over the whole of the 24-hour period. It will be quantified as the ratio of low frequency to high frequency HRV components over these periods. 2. The number of aggressive episodes will be counted from the behavioural diaries completed every day through the study. Specific aspects of their presentation will be rated using The Challenging Behaviour Interview (Oliver et al. 2003), The Behaviour Problems Inventory (Rojahn et al. 2001) and the Aberrant Behaviour Checklist (Aman et al. 1985) collected in baseline-1 week 1, sham week 2, active phase week 5 and baseline-2 week 4. 3. Changes in emotional state will be assessed using the Hospital Anxiety and Depression scale, the self-report State-Trait Anger Expression Inventory-2 (STAXI-2). Emotional state will be measured in baseline-1 week 1, baseline-1 week 5, sham week 2, active week 5, baseline-2 week 4. 4. Changes in psychological (executive function and hostility bias) state will be assessed as follows: 4.1. The Dysexecutive Questionnaire (DEX; Burgess et al 1998): self-report version 4.2. Working memory capacity: Digit Span (Forwards and Backwards) from the WAIS-IV 4.3. Concept formation and switching: Wisconsin Card Sort Test (WCST) (Weigl card sort test) 4.4. Working memory control: Letter number sequencing from the WAIS-IV 4.5. Digit Span (Backwards) from the WAIS-IV 4.6. Inhibition and switching: Colour-word interference test (Stroop) from the D-KEFS (‘Cat-dog’ Stroop test) 4.7. Potential hostility bias: the | — |
Countries
United Kingdom
Outcome results
None listed