Single pulse transcranial magnetic stimulation (sTMS) for the acute treatment of migraine
- At 3 months, there was a reduction in monthly headache days for episodic migraine, from median (IQR): 12 (8–13) to 9 (4–12) and for chronic migraine, a reduction from 24 (6–30) to 16 (10–30).
- A total of 62% of 190 patients surveyed at three months reported pain relief, finding the sTMS device effective at reducing or alleviating migraine pain.
Migraine is one of the most common neurological disorders that may lead to disability. In some cases, lifestyle changes may be helpful. Others may be troublesome requiring management of migraine attacks and its frequency.
Migraine is one of the most common neurological disorders that may lead to disability. In some cases, lifestyle changes may be helpful. Others may be troublesome requiring management of migraine attacks and its frequency. Side effects, for example, weight increase due to numerous preventives, or vascular issues with acute attack treatments, or both, are matter of concern and encourage the development of new compelling and well tolerated treatments. Single pulse transcranial stimulation (sTMS) is a non-invasive, safe, painless and effective treatment for acute migraine in patients with aura. It works by activating the human motor cortex and is based on the principle of electromagnetic induction.
Rationale behind research
- Migraine has a considerable burden on patients and society
- Single pulse transcranial stimulation is a non-invasive, safe, painless and effective treatment for acute migraine in patients with aura with a good tolerability profile
To assess the effect of sTMS on migraine symptoms and treatment during a three month treatment period on:
- Impact on pain severity
- Symptoms of related migraine
- Duration of attack
- Acute medication use
- Primary outcome: Migraine day, characterized as any day when there was head pain of moderate or extreme intensity pain scale ≥4 out of a 0 - 10 scale lasting at least 4 hours and satisfying current criteria.
- Secondary outcomes
- A migraine attack characterized as a progression of migraine days ended by a non-migraine day, and a headache day, which was a day with any migraine of any seriousness for 60 minutes
- Pain, associated symptoms, reduced attack duration, disability and overall effect
- Tolerability and safety
- Three pregnant patients were also evaluated
- Efficacy: Baseline, 3 months
Baseline: The two treatment groups were well balanced at baseline
- Primary outcome: Migraine days /month
- At baseline: Median (IQR) = 15 (10-20)
- At 6 weeks: Median (IQR) = 11 (6-16)
- At 12 weeks: Median (IQR) = 8 (3-13)
- Subgroup data: At 3 months, there was reduction in monthly headache days for episodic migraine, from median (IQR): 12 (8–13) to 9 (4–12) and for chronic migraine, reduction from 24 (6–30) to 16 (10–30)
- Secondary outcome
- Pain severity
- Baseline: 0 patient evaluated at subscale 0 and 18 patient at subscale 10
- At 6 weeks: 3 patient evaluated at subscale 0 and 4 at subscale 10
- At 12 weeks: 2 patient evaluated at subscale 0 and 3 at subscale 10
- HIT Scores (Evaluable N=139)
- At Baseline: Median (IQR) = 66 (62–70)
- At 12 weeks: Median (IQR) =61 (56–66)
- Pain severity
- Binary outcome on basis of HIT scores
- No change: 19 (14%) patients
- Higher score posttreatment: 20 (14%) patients
- Lower score post treatment: 100 (72 %)
- Pain: Pain reduction reported in 118/190 patients
- Attack duration: Number of headache days per attack reduced in 102/185 patients
- At least one associated symptoms of nausea, photophobia or phonophobia reported in 174/190 patients
- Transient light-headedness in 38/190 patients
- Side effects of either tinnitus, dizziness or tingling in 19/190 patients
- Discontinuations in 105/190 patients
- No benefit or inadequate benefit in 49 patients
NOTE: Three pregnant patients reported reduction in pain severity, shorter attack duration and reduction in severity of associated symptoms
The sTMS device showed safety, efficacy and better tolerability as an acute migraine treatment in open clinic settings.
In spite limitations, the outcomes were generally positive and the therapy was very well tolerated. sTMS may be considered as safe and a valuable addition to the treatment of both episodic and chronic migraine.