1. No category

Update of the UK post market pilot programme with single pulse transcranial magnetic stimulation (sTMS) for
acute treatment of migraine
R. Bhola 1, E. Kinsella 1, F. Ahmed 2, P.J. Goadsby 3
1eNeura Inc., CA USA, 2Department of Neurology, Hull Royal Infirmary, Hull and 3NIHR-Wellcome Trust Clinical Research Facility, King’s College London,
UK
Background
Results
• Some patients suffer disabling, frequent migraine
without effective treatment as current pharmacological
options are either contra-indicated, poorly tolerated or
overused.
• The non-invasive, portable, sTMS device is designed for
patient use and received a CE mark in 2011 for the acute
treatment of migraine.
• In a previously published, randomised, sham-controlled
study, SpringTMS was shown to be effective for the
acute treatment of migraine with aura1 .
• The safety of sTMS in clinical practice, including as an
acute migraine treatment, is supported by biological,
empirical, and clinical trial evidence.2
• A post market pilot programme with the SpringTMS
device was initiated for patients with migraine.
• The National Institute for Clinical Excellence3 (NICE)
approved TMS for acute and preventive treatment of
migraine in the UK.
• 122 (35%) patients have been using the device for a minimum of
three months and completed surveys. A total of 351 patients
have been prescribed sTMS.
• 88 patients (72%) reported a reduction or alleviation of pain.
• Associated symptoms (nausea 64%; photophobia 84%;
phonophobia 89%) improved or did not develop.
• A reduction in the number of headache days was reported by 76
(62%).
• 71 (58%) reported a reduction in the duration of migraine
symptoms per attack.
• 101 (83%) were also using an acute medication at the time of
prescription. Of these, 69 (68%) reported a reduction in the
number of days of medications use.
• The treatment was well tolerated with no serious adverse events
reported.
• For those patients who reported clinical response, these were
reproducible throughout the 3 month period and beyond.
130
17
110
2
24
41
100
90
80
Pain Free
70
Mild
63
60
Moderate
46
99
50
Severe
Excruciating
40
30
20
31
32
2
1
10
6
0
Baseline
6 Weeks
12 Weeks
Figure 3: Effectiveness on Pain
30
Objectives
2
120
25
• Evaluate responses in an open outpatient setting
• Understand patient support and educational needs
• Assist patients in establishing optimal treatment
schemes for their migraine patterns
• Review options for sTMS within the UK headache care
pathway
20
15
15
5
10
5
0
CM Baseline
Methods
CM 6 weeks CM 12 Weeks EM Baseline
n = 78
Clinicians selected patients and prescribed the device.
Patients received the device to use for a minimum period
of three months. A specialist nurse had first contact with
the patient to discuss treatment and use. Telephone
reviews were conducted at 4 to 6-weekly intervals to
support and monitor the patients’ treatment and progress.
Survey data was collected at the 6 and 12-week time
points over the treatment period.
n =101
10
EM 6 Weeks EM 12 Weeks
n=44
Chane in Med Acute Days/Month
Migraine Days/Month
• Assess impact on pain, associated migraine symptoms
and acute medication use over an extended period
(minimum three months)
Acute Med Reduction
n = 69
No Reduction
n = 24
0
Acute Med
Increase
n=8
-5
-10
-15
-20
Figure 1: Change in headache days
-25
-30
4.00
Figure 4: SpringTMS Reduction of Acute
Medicine Days
n = 122
3.00
Patient Characteristics
Mean Duration in Days
2.00
1.00
Reduction
n = 71
No Change
n = 48
Conclusion
0.00
# of
Migraine Features
Patients
# of
Attacks
Treated
Migraine with aura
61
3072
Migraine without aura
61
2253
Of these:
Increase
n=3
-1.00
-2.00
-3.00
-4.00
• SpringTMS is a new and effective NICE UKapproved, acute and adjunctive, non-drug
treatment option for patients with migraine.
• These results are consistent with this CE
marked device being safe to use in
outpatient practice.
• The data suggests the device, in responders,
continues to provide reliable, reproducible
effects on migraine over time.
Figure 2: Reduction in Attack Duration
Episodic
44
1704
Chronic
78
3621
This programme was sponsored by eNeura Inc.
Acknowledgements: Headache Specialists also participating in the programme: S Lipscombe, N Giffin, M Weatherall, G Elrington, D Kernick; R
Peatfield; K Shields; N Silver; B Davies; D Watson, F Maniyar, A Dowson, P Booton
1 Lipton R.B., Dodick D.W., Silberstein S.D et al. Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: randomized, double-blind, parallel-group, sham controlled trial. The Lancet Neurology 2010;9:373-380.
2 Dodick D.W, Schembri C.T., Helmuth M et al. Transcranial magnetic stimulation for migraine: a safety review. Headache 2010; 50:1153-1163.
3 NICE www.nice.org.uk/IPG477