Transcutaneous vagal nerve stimulation for episodic aggressio

Completed

• Conditions: Developmental and acquired brain injury; Injury, Occupational Diseases, Poisoning; Intracranial injury, unspecified

• Registration Number: ISRCTN16552390
• Lead Sponsor: Cambridge and Peterborough NHS Foundation Trust (UK)

Brief Summary

1. 2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29457585.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-07-26
• Study Completion: 2017-05-31
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> The feasibility of delivering the intervention, which will be determined as follows:<br> 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.<br> 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.<br>