Title: Sustained treatment of Idiopathic Intracranial Hypertension (IIH) through weight loss induced by bariatric surgery
Funder: Department of Health and Social Care

Abstract: Idiopathic intracranial hypertension, (IIH), is a common blinding condition in overweight women. The best way to treat IIH is not known. Drugs e.g acetazolamide, have not been shown to be effective. Shunting surgery can be used to save vision, but shunts block in over half of patients and therefore need replacing, often multiple times. The other treatment option is weight loss. We have just performed a seminal study to prove that weight loss (about 15% of body weight) reduces intracranial pressure (ICP) and treats IIH. However, following the diet, patients regained weight and their IIH returned. Alternative weight loss strategies such as tablets and injections will not reduce weight enough to treat IIH and additionally are short term options. Lasting weight loss is needed to treat IIH in the long term. This can be achieve through gastric (stomach) banding surgery. The National Institute for Clinical Excellence (NICE) has concluded that this surgery is a safe and cost effective treatment for obesity. We propose a randomised controlled trial of gastric banding surgery compared to standard treatment by hospital dietetics services, to treat IIH. We appreciate that a surgical intervention raises ethical concerns, however, the surgery will follow the reputable NICE guidelines, additionally, patients will only be recruited following informed consent. The trial will be conducted at University Hospitals Birmingham NHS Foundation Trust (an ideal setting for the study as we run a large specialist IIH clinic with onsite collaborations with the Birmingham Clinical Trials Unit and health economists). We will evaluate ICP (primary outcome), as well as headache and visual function. This study will be used to inform, and rollout into, a future multicentre trial which will evaluate cost effectiveness and quality of life.

Lay abstract: Idiopathic intracranial hypertension, (IIH), is a common blinding condition in overweight women. The best way to treat IIH is not known. Drugs e.g acetazolamide, have not been shown to be effective. Shunting surgery can be used to save vision, but shunts block in over half of patients and therefore need replacing, often multiple times. The other treatment option is weight loss. We have just performed a seminal study to prove that weight loss (about 15% of body weight) reduces intracranial pressure (ICP) and treats IIH. However, following the diet, patients regained weight and their IIH returned. Alternative weight loss strategies such as tablets and injections will not reduce weight enough to treat IIH and additionally are short term options. Lasting weight loss is needed to treat IIH in the long term. This can be achieve through gastric (stomach) banding surgery. The National Institute for Clinical Excellence (NICE) has concluded that this surgery is a safe and cost effective treatment for obesity. We propose a randomised controlled trial of gastric banding surgery compared to standard treatment by hospital dietetics services, to treat IIH. We appreciate that a surgical intervention raises ethical concerns, however, the surgery will follow the reputable NICE guidelines, additionally, patients will only be recruited following informed consent. The trial will be conducted at University Hospitals Birmingham NHS Foundation Trust (an ideal setting for the study as we run a large specialist IIH clinic with onsite collaborations with the Birmingham Clinical Trials Unit and health economists). We will evaluate ICP (primary outcome), as well as headache and visual function. This study will be used to inform, and rollout into, a future multicentre trial which will evaluate cost effectiveness and quality of life.

Research activity codes: 6.4 SURGERY
Health categories: NEUROLOGICAL;EYE