Deep Brain Stimulation for Hypertension VERSION 2

• Research type

  Research Study

• Full title

  Deep Brain Stimulation for Hypertension

• IRAS ID

  187907

• Contact name

  Helen Lewis

• Contact email

  researchsponsor@nbt.nhs.uk

• Sponsor organisation

  North Bristol NHS Trust

• Duration of Study in the UK

  6 years, 0 months, 1 days

• Research summary

  High blood pressure (hypertension) affects around a quarter of the adult population worldwide and is a major risk factor for stroke, heart and kidney disease. These risks increase as blood pressure rises; they also increase with increasing age and obesity, issues of pressing relevance to our population. Not only is the asymptomatic presentation of hypertension a problem, diagnosis relies on screening and antihypertensive medicines bring side effects that may affect complicance. In addition, it is estimated that 20-30% of patients are ’resistant’ to this treatment, meaning their blood pressure cannot be controlled using three different types of antihypertensive medications at maximum doses. These patients are at particularly high risk of complications, such as stroke. We propose a much needed and novel intervention, that of deep brain stimulation of a midbrain region. We wish to build on a remarkable observation where deep brain stimulation of the midbrain relieved severe refractory hypertension, and the hypothesis is that it is possible to ’reset’ the nervous system coordinating centre for blood pressure control. Capitalising on unique local clinical and academic multidisciplinary expertise, we will implant stimulators in up to 6 patients with either resistant hypertension or hypertensive patients receiving deep brain stimulation for other reasons, to substantiate this as an effective antihypertensive treatment. We will measure the longevity of any hypotensive effect and whether chronic stimulation can reset the central setpoint of arterial pressure. Initial investigations to confirm blood pressure status, assess for cardiovascular risk, in addition to looking for inflammatory mediators (including the F11R a postulated inflammatory marker found at elevated levels in the brainstems of hypertensive rats and in one human study of peripheral blood) and undertaking a preoperative MRI scan to assess whether there are problems with the blood supply to the brain stem that may underlie the development of high blood pressure.

• REC name

  South West - Central Bristol Research Ethics Committee

• REC reference

  16/SW/0093

• Date of REC Opinion

  22 Jun 2016

• REC opinion

  Further Information Favourable Opinion