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RecruitingNAINTERVENTIONAL

IIH Intervention: A Clinical Trial Comparing 2 Treatments (Shunts and Stents) Evaluation Of Clinical Effectiveness And Cost Effectiveness

If you have Idiopathic Intracranial Hypertension (IIH) and are at risk of losing your sight, this study might be for you. IIH is a condition where there's too much pressure inside your head, causing headaches, blurry vision, and ringing in the ears. Left untreated, it can lead to blindness. While most people manage IIH with weight loss and medication, some need an urgent procedure to save their vision. This study compares two existing treatments: shunts (tubes to drain fluid) and stents (small mesh tubes in blood vessels). The aim is to discover which procedure works best to protect vision and offers the best value. Participants will be randomly assigned one of these treatments and closely monitored for two years in NHS hospitals across the UK.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University of Birmingham
Enrolment target
80
Start
18 Jul 2023
Estimated completion
28 May 2028

What is this study about?

Idiopathic Intracranial Hypertension (IIH) is a condition that affects the brain, specifically causing high pressure inside your skull. This increased pressure can lead to symptoms like persistent headaches, blurred vision, and a pulsing sound in your ears. It is more commonly found in women of childbearing age who are overweight. The good news is that for most people with IIH, managing their weight and taking specific medicines can help control the condition. However, for a small number of people, the vision can get worse quickly, and they need an urgent treatment to lower this pressure and protect their eyesight.

This study, called "IIH Intervention", is looking at two common procedures used in the UK for these urgent cases: CSF shunting and dural venous sinus stenting (DVSS). Shunting involves a small operation to put a thin tube into your body to gently drain away some of the fluid around your brain. Stenting is a procedure where a small, mesh tube is placed inside a blood vessel in your brain to help it stay open. Both of these treatments are already being used, but doctors don't yet have enough information to say which one is consistently better at saving vision and more cost-effective for the NHS. This research hopes to provide that important information by comparing these two treatments directly.

By taking part, you would be helping researchers discover which of these existing treatments offers the most benefit to patients with IIH who are at risk of losing their sight. The aim is to genuinely improve how people with this condition are treated in the future, helping to ensure that the most effective and efficient care is provided across the UK.

Key takeaways

  • Compares two existing IIH treatments: shunts and stents.
  • Aims to find the most effective and cost-efficient treatment for vision protection.
  • For adults with IIH at risk of sight loss.
  • Involves random assignment to one of the two treatments.
  • Two years of follow-up with hospital and phone appointments.
  • Data collected will improve future IIH care in the UK.

Who may be eligible?

This study is looking for adults aged between 18 and 63 who have been diagnosed with IIH and are at risk of losing their sight. You must have swelling of the optic nerve (the nerve connecting your eye to your brain) in at least one eye, which is a sign your vision is at risk. It's important that you could safely have, and would be willing to undergo, either of the two treatments being compared – the shunt or the stent.

There are some reasons why you wouldn't be able to join. For example, if you've already had surgery for IIH, such as a previous shunt or stent, or if you've had weight-loss surgery recently. People with certain severe allergies, or other medical conditions that could make participating unsafe or complicate the study results, also wouldn't be able to take part. This includes being pregnant, or having signs of blood clots in your brain's veins.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you an adult aged 18 to 63?
  2. Have you been diagnosed with IIH and are your doctors concerned about your vision?
  3. Do you have swelling of the optic nerve in at least one eye?
  4. Would you be willing and able to have either a shunt or a stent procedure?
  5. Have you not had previous surgery for IIH or recent weight-loss surgery?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would first need to sign a consent form. Then, you would be randomly assigned to receive either the CSF shunting procedure or the dural venous sinus stenting (DVSS) procedure. This is like flipping a coin – you have an equal chance of receiving either treatment. After your procedure, you'll have a series of follow-up appointments. This involves 11 visits to the hospital and one phone call over a period of two years. During these appointments, the research team will carefully monitor your vision, headaches, and general well-being. They will also check for any side effects from your treatment or if the device (shunt or stent) isn't working as it should. The study will last approximately two years from your initial treatment.

Potential risks and benefits

There isn't a direct personal benefit from taking part in this trial beyond the treatment you would already receive. However, you might find that you feel more supported due to the regular check-ups and close attention from the study team. Both shunting and stenting are established treatments for IIH, so you won't be receiving an experimental treatment that isn't already used in clinical practice. As with any medical procedure, there are potential risks and complications associated with both shunting and stenting, which your doctor will explain in detail. The study itself doesn't add any extra risks beyond those already present with these standard treatments. Your participation will greatly help doctors understand which treatment is best for future patients with IIH, and you are free to withdraw from the study at any time.

Locations (15)

  • The Queen Elizabeth Hospital
    Verified postcode
    Birmingham, United Kingdom· Recruiting
  • Bristol Eye Hospital
    Verified postcode
    Bristol, United Kingdom· Not yet recruiting
  • Southmead Hospital
    Verified postcode
    Bristol, United Kingdom· Not yet recruiting
  • Addenbrooke's Hospital
    Verified postcode
    Cambridge, United Kingdom· Recruiting
  • University Hospital of Wales
    Verified postcode
    Cardiff, United Kingdom· Recruiting
  • Princess Alexandra Eye Pavillion
    Verified postcode
    Edinburgh, United Kingdom· Recruiting
  • Queen Elizabeth University Hospital
    Verified postcode
    Glasgow, United Kingdom· Recruiting
  • Royal Hull Infirmary
    Verified postcode
    Hull, United Kingdom· Recruiting
  • Leeds General Infirmary
    Verified postcode
    Leeds, United Kingdom· Recruiting
  • King's College Hospital
    Verified postcode
    London, United Kingdom· Recruiting
  • National Hospital for Neurology and Neurosurgery
    Verified postcode
    London, United Kingdom· Recruiting
  • Royal Victoria Infirmary
    Verified postcode
    Newcastle, United Kingdom· Recruiting

Common questions

What is IIH?

IIH, or Idiopathic Intracranial Hypertension, is a condition where there's too much pressure inside your head, causing symptoms like headaches and vision problems.

What are shunts and stents?

Shunts are tubes placed to drain fluid from the brain, and stents are small mesh tubes placed in blood vessels, both designed to lower pressure inside the head.

Will I choose my treatment?

No, you'll be randomly assigned to either the shunt or stent group. This ensures a fair comparison between the two treatments.

How long will the study last for me?

Your involvement in the study will last for two years, including follow-up appointments after your procedure.

Is this a new, experimental treatment?

No, both shunts and stents are standard treatments for IIH, but this study aims to find out which one is better.

How to find out more

Alexandra Sinclair, MBChB, FRCP, PhD

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "IIH Intervention: A Clinical Trial Comparing 2 Treatments (S…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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