tVNS for episodic aggression: A feasibility and pilot study
Research type
Research Study
Full title
tVNS for episodic aggression: A feasibility and and single case experimental design pilot study
IRAS ID
205596
Contact name
Howard Ring
Contact email
Sponsor organisation
Cambridgeshire and Peterborough NHS Foundation Trust and the University of Cambridge
Duration of Study in the UK
0 years, 9 months, 31 days
Research summary
Unmet clinical need: Repeated aggressive behaviours occur particularly often in adults with developmental or acquired impairments of cognitive, social and/or emotional functioning, occurring in 10 - 15% of people with an intellectual disability, 10 - 35% of people with acquired brain injury and up to 60% of people with autism. They are often not adequately managed by existing treatments.
A potential management: Research has demonstrated associations between vagus nerve modulation of heart rate and brain systems involved with cognitive flexibility and emotion regulation. We will investigate transcutaneous vagus nerve stimulation (tVNS) modulation of heart rate variability (HRV) to reduce aggressive behaviours. In tVNS device a weak current is delivered through a small stimulator worn in the outer ‘shell’ of one ear where it stimulates a branch of the vagus nerve.
The study aims to establish ‘proof of principle’, using single case methodology, that: 1. tVNS is acceptable. 2. It reduces frequency of episodic aggressive behaviours in adults with developmental or acquired brain injury or autism. 3. Reduced episodic aggressive behaviours are associated with increases in HRV. 4. tVNS improves cognitive flexibility.
What we plan to do: We will recruit 12 adults with repeated mild-moderately aggressive episodes and acquired or developmental brain injury, or autism. All 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 some problem solving and emotion-recognition tests performed. The first and fourth phases will be for initial and final baseline recording. In the second, control, phase participants will wear the tVNS device for four 1-hour periods per day – with the device mostly switched off. In the third ‘active’ phase the tVNS device is kept on for four 1-hour periods per day.REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
16/EE/0329
Date of REC Opinion
25 Aug 2016
REC opinion
Further Information Favourable Opinion