Occipital nerv

nervee stimulation for intr

intractable
actable
chronic migr
migraine
aine
Interventional procedures guidance
Published: 26 April 2013
nice.org.uk/guidance/ipg452

Your responsibility

This guidance represents the view of NICE, arrived at after careful consideration of the evidence
available. When exercising their judgement, healthcare professionals are expected to take this
guidance fully into account. However, the guidance does not override the individual responsibility
of healthcare professionals to make decisions appropriate to the circumstances of the individual
patient, in consultation with the patient and/or guardian or carer.

Commissioners and/or providers have a responsibility to implement the guidance, in their local
context, in light of their duties to have due regard to the need to eliminate unlawful discrimination,
advance equality of opportunity, and foster good relations. Nothing in this guidance should be
interpreted in a way that would be inconsistent with compliance with those duties.

Commissioners and providers have a responsibility to promote an environmentally sustainable

health and care system and should assess and reduce the environmental impact of implementing
NICE recommendations wherever possible.

1 Guidance

1.1 The evidence on occipital nerve stimulation (ONS) for intractable chronic
migraine shows some efficacy in the short term but there is very little evidence
about long-term outcomes. With regard to safety, there is a risk of
complications, needing further surgery. Therefore, this procedure should only

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Occipital nerve stimulation for intractable chronic migraine (IPG452)

be used with special arrangements for clinical governance, consent, and audit or
research.

1.2 Clinicians wishing to undertake ONS for intractable chronic migraine should
take the following actions:

Inform the clinical governance leads in their Trusts.

Ensure that patients understand the uncertainty about the procedure's safety and
efficacy, and provide them with clear written information. In addition, the use of
NICE's information for the public is recommended.

1.3 Selection of patients for treatment using ONS for intractable chronic migraine
should be done by a multidisciplinary team, including specialists in headache,
pain management and neurosurgery.

1.4 Clinicians should enter details about all patients undergoing ONS for intractable
chronic migraine onto the UK Neuromodulation Register when access to that
database is available. They should audit and review clinical outcomes locally and
should document and consider their relationship to patient characteristics.

1.5 NICE encourages publication of further information from comparative studies

and from collaborative data collection to guide future use of this procedure and
to provide patients with the best possible advice. Publications should include
full details of any complications, and of adjunctive or subsequent treatments.
Outcomes should include measures of pain, function and quality of life,
particularly in the long term.

1.6 NICE may review the procedure on publication of further evidence.

2 The procedure

2.1 Indications and current treatments

2.1.1 Migraine is a severe headache, often accompanied by sensitivity to light and

sound. It may be preceded by an aura, consisting of perception of an unusual
light, an unpleasant smell or, occasionally, confusing thoughts or experiences.
The International Classification of Headache Disorders (International Headache
Society 2004) provides a classification of migraine types.

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Occipital nerve stimulation for intractable chronic migraine (IPG452)

2.1.2 Current treatment for patients with migraine aims to prevent or stop episodes
with drugs such as painkillers, anti-emetics and triptans (as recommended in
NICE clinical guideline 150). If these fail, invasive treatments such as nerve
blocks, botulinum toxin type A (NICE technology appraisal guidance 260) or
acupuncture are sometimes used.

2.2 Outline of the procedure

2.2.1 ONS for intractable chronic migraine is usually done in 2 stages, although a
single-stage procedure is sometimes used. In the first, trial stage, using local
anaesthesia and usually with fluoroscopic guidance, electrodes are passed
through a subcutaneous tunnel and placed over the occipital nerve(s) around
the level of C1. Correct placement of electrodes is verified by intraoperative
stimulation and patient feedback before they are sutured to subcutaneous
tissue. A lead is tunnelled under the skin from the electrode to an exit site in the
posterior cervical region, where it is connected by an external extension lead to
a hand-held neurostimulator.

2.2.2 The second stage is carried out if the trial is successful. With the patient under
general anaesthesia, an implantable neurostimulator is secured in a
subcutaneous pocket, usually in the infraclavicular region or the abdominal wall.
A lead is tunnelled from the electrode to the implantable neurostimulator. The
patient uses a remote control to stimulate the occipital nerves when needed.

Sections 2.3 and 2.4 describe efficacy and safety outcomes from the published
literature that the Committee considered as part of the evidence about this procedure.
For more detailed information on the evidence, see the systematic review and the
addendum to the systematic review.

2.3 Efficacy

2.3.1 A randomised controlled trial (RCT) of 157 patients compared ONS (active
stimulation, n=105) against sham stimulation (n=52). It reported a statistically
significantly greater decrease in the 'Migraine disability assessment score'
(MIDAS), which takes into account headache days and their impact on the
patient's life (maximum score 200), at 12-week follow-up for the ONS group
than for the sham stimulation group (64.6 and 20.4 reduction respectively,
p=0.001).

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Occipital nerve stimulation for intractable chronic migraine (IPG452)

2.3.2 An RCT of 67 patients comparing ONS (n=33) against sham stimulation (n=17)
or medical management (n=17) reported a responder rate (defined as a
reduction in headache days per month of 50% or more, or a 3-point or greater
reduction in average overall pain intensity compared with baseline at 3 months)
of 39% (11/28) in the ONS group, 6% (1/16) in the sham stimulation group and
0% (0/17) in the medication group (p value not reported).

2.3.3 A case series of 25 patients reported that headache frequency per 90 days
reduced from 75.56 (standard deviation [SD] 26.81) before implantation to
37.45 (SD 7.49) over a mean follow-up of 18 months (p<0.001).

2.3.4 The RCT of 157 patients reported no significant difference between the groups
in the proportion of patients whose pain reduced by 50% or more (measured on
a visual analogue scale) (17% for ONS and 14% for sham stimulation, p=0.55) at
12-week follow-up.

2.3.5 The case series of 25 patients reported a significant reduction in headache

severity (010 scale) from a baseline of 9.32 (SD 1.28) to 5.72 (SD 3.31) over a
mean follow-up of 18 months (p<0.001).

2.3.6 The Specialist Advisers listed key efficacy outcomes as a reduction in migraine
or headache days, headache severity, frequency and duration, disability score
(measured by MIDAS), medication use and improvements in quality of life
(SF-36).

2.4 Safety

2.4.1 Infections at the implant site were reported in 14% (7/51) of patients in the RCT
of 67 patients at 3-month follow-up. Infection was reported in 4% (4/105) of
patients in the ONS group and 6% (3/52) of patients in the sham stimulation
group in the RCT of 157 patients at 12-week follow-up (no further details
available).

2.4.2 Skin erosion was reported in 4% (4/105) of patients in the ONS group and 4%
(2/52) of patients in the sham stimulation group in the RCT of 157 patients at
12-week follow-up.

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Occipital nerve stimulation for intractable chronic migraine (IPG452)

2.4.3 Lead migration or dislodgement was reported in 10% (5/52) of patients in the
sham stimulation group and 14% (15/105) of patients in the ONS group in the
RCT of 157 patients after 3 months; and in 24% (12/51) of patients in the RCT of
67 patients at 3-month follow-up. Lead migration was reported in 36% (9/25) of
patients in the case series of 25 patients at mean 18-month follow-up.

2.4.4 Problems with ineffective device programming and ineffective leads were
reported in 12% (6/51) and 4% (2/51) of patients respectively, in the RCT of
67 patients at 3-month follow-up.

2.4.5 Persistent pain or numbness at the implant site was reported in 13% (14/105) of
patients in the ONS group and 17% (9/52) of patients in the sham stimulation
group in the RCT of 157 patients at 12-week follow-up. Loss of motor or
musculoskeletal control was reported in 1% (1/105) of patients in the ONS
group in the same RCT (timing not reported).

2.4.6 Unintended stimulation effect (no further details available) was reported in 6%
(6/105) of patients in the ONS group and 2% (1/52) of patients in the sham
stimulation group in the RCT of 157 patients.

2.4.7 In addition to the above, the Specialist Advisers listed haemorrhage, nerve
damage and lead fracture as theoretical adverse events.

2.5 Other comments

2.5.1 The Committee recognised that patients being considered for ONS for
intractable chronic migraine commonly have very distressing and long-term
symptoms that other methods of treatment have failed to control.

2.5.2 The Committee recognised that research in this area is difficult because there is
uncertainty about the percentage level of relief that should be considered
significant and it is difficult to achieve blinding in trials, and because of the
complex and heterogeneous nature of chronic migraine. Currently, there are not
enough good-quality comparative studies to be able confidently to evaluate the
procedure's efficacy. This underpins the recommendations in section 1.

2.5.3 The Committee recognised that techniques and technology are evolving and,
implicitly, this may produce better results.

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Occipital nerve stimulation for intractable chronic migraine (IPG452)

3 Further information

3.1 For related NICE guidance, see the NICE website.

Information for patients

NICE has produced information on this procedure for patients and carers (Information for the
public). It explains the nature of the procedure and the guidance issued by NICE, and has been
written with patient consent in mind.

About this guidance

NICE interventional procedure guidance makes recommendations on the safety and efficacy of the
procedure. It does not cover whether or not the NHS should fund a procedure. Funding decisions
are taken by local NHS bodies after considering the clinical effectiveness of the procedure and
whether it represents value for money for the NHS. It is for healthcare professionals and people
using the NHS in England, Wales, Scotland and Northern Ireland, and is endorsed by Healthcare
Improvement Scotland for implementation by NHSScotland.

This guidance was developed using the NICE interventional procedures guidance process.

We have produced a summary of this guidance for patients and carers.

Your
ourresponsibility
responsibility
This guidance represents the views of NICE and was arrived at after careful consideration of the
available evidence. Healthcare professionals are expected to take it fully into account when
exercising their clinical judgement. This guidance does not, however, override the individual
responsibility of healthcare professionals to make appropriate decisions in the circumstances of
the individual patient, in consultation with the patient and/or guardian or carer.

Implementation of this guidance is the responsibility of local commissioners and/or providers.

Commissioners and providers are reminded that it is their responsibility to implement the
guidance, in their local context, in light of their duties to have due regard to the need to eliminate
unlawful discrimination, advance equality of opportunity and foster good relations. Nothing in this
guidance should be interpreted in a way that would be inconsistent with compliance with those
duties.

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conditions#notice-of-rights). 7
Occipital nerve stimulation for intractable chronic migraine (IPG452)

Cop
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yright
National Institute for Health and Care Excellence, 2013. All rights reserved. NICE copyright
material can be downloaded for private research and study, and may be reproduced for educational
and not-for-profit purposes. No reproduction by or for commercial organisations, or for
commercial purposes, is allowed without the written permission of NICE.

Contact
ContactNICE
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www.nice.org.uk

[email protected]

0845 033 7780

ISBN 978-1-4731-0099-2

Endorsing organisation

This guidance has been endorsed by Healthcare Improvement Scotland.

Accreditation

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