A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)

Amaal J. Starling, Stewart J. Tepper, Michael J. Marmura, Ejaz A. Shamim, Matthew S. Robbins, Nada Hindiyeh, Andrew C. Charles, Peter J. Goadsby, Richard B. Lipton, Stephen D. Silberstein, Amy A. Gelfand, Richard P. Chiacchierini, David W. Dodick

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Objective: To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background: sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods: The e Neura S pringTMS P ost-Market O bservational U.S. S tudy of Migrain e (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results: Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (−0.63 days) (p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher (p < 0.0001) than the performance goal (20%). There was a reduction of −2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, −3.1 (6.4) (p < 0.0001), and total headache days of any intensity −3.16 days (5.21) compared to the performance goal (−0.63 days) (p < 0.0001). The most common adverse events were lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%). There were no serious adverse events. Conclusions: This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention. Trial registration number: NCT02357381

Original languageEnglish (US)
JournalCephalalgia
DOIs
StateAccepted/In press - Jan 1 2018

Fingerprint

Transcranial Magnetic Stimulation
Migraine Disorders
Observational Studies
Headache
Therapeutics
Migraine with Aura
Equipment and Supplies
Intention to Treat Analysis
Tinnitus
Dizziness
Clinical Protocols
Placebos
Safety

Keywords

  • Migraine
  • preventive treatment
  • single-pulse
  • transcranial magnetic stimulation

ASJC Scopus subject areas

  • Clinical Neurology

Cite this

Starling, A. J., Tepper, S. J., Marmura, M. J., Shamim, E. A., Robbins, M. S., Hindiyeh, N., ... Dodick, D. W. (Accepted/In press). A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study). Cephalalgia. https://doi.org/10.1177/0333102418762525

A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study). / Starling, Amaal J.; Tepper, Stewart J.; Marmura, Michael J.; Shamim, Ejaz A.; Robbins, Matthew S.; Hindiyeh, Nada; Charles, Andrew C.; Goadsby, Peter J.; Lipton, Richard B.; Silberstein, Stephen D.; Gelfand, Amy A.; Chiacchierini, Richard P.; Dodick, David W.

In: Cephalalgia, 01.01.2018.

Research output: Contribution to journalArticle

Starling, AJ, Tepper, SJ, Marmura, MJ, Shamim, EA, Robbins, MS, Hindiyeh, N, Charles, AC, Goadsby, PJ, Lipton, RB, Silberstein, SD, Gelfand, AA, Chiacchierini, RP & Dodick, DW 2018, 'A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)', Cephalalgia. https://doi.org/10.1177/0333102418762525
Starling, Amaal J. ; Tepper, Stewart J. ; Marmura, Michael J. ; Shamim, Ejaz A. ; Robbins, Matthew S. ; Hindiyeh, Nada ; Charles, Andrew C. ; Goadsby, Peter J. ; Lipton, Richard B. ; Silberstein, Stephen D. ; Gelfand, Amy A. ; Chiacchierini, Richard P. ; Dodick, David W. / A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study). In: Cephalalgia. 2018.
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abstract = "Objective: To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background: sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods: The e Neura S pringTMS P ost-Market O bservational U.S. S tudy of Migrain e (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50{\%} responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results: Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (−0.63 days) (p < 0.0001). The 50{\%} responder rate of 46{\%} (95{\%} CI 37{\%}, 56{\%}) was also significantly higher (p < 0.0001) than the performance goal (20{\%}). There was a reduction of −2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, −3.1 (6.4) (p < 0.0001), and total headache days of any intensity −3.16 days (5.21) compared to the performance goal (−0.63 days) (p < 0.0001). The most common adverse events were lightheadedness (3.7{\%}), tingling (3.2{\%}), and tinnitus (3.2{\%}). There were no serious adverse events. Conclusions: This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention. Trial registration number: NCT02357381",
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T1 - A multicenter, prospective, single arm, open label, observational study of sTMS for migraine prevention (ESPOUSE Study)

AU - Starling, Amaal J.

AU - Tepper, Stewart J.

AU - Marmura, Michael J.

AU - Shamim, Ejaz A.

AU - Robbins, Matthew S.

AU - Hindiyeh, Nada

AU - Charles, Andrew C.

AU - Goadsby, Peter J.

AU - Lipton, Richard B.

AU - Silberstein, Stephen D.

AU - Gelfand, Amy A.

AU - Chiacchierini, Richard P.

AU - Dodick, David W.

PY - 2018/1/1

Y1 - 2018/1/1

N2 - Objective: To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background: sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods: The e Neura S pringTMS P ost-Market O bservational U.S. S tudy of Migrain e (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results: Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (−0.63 days) (p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher (p < 0.0001) than the performance goal (20%). There was a reduction of −2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, −3.1 (6.4) (p < 0.0001), and total headache days of any intensity −3.16 days (5.21) compared to the performance goal (−0.63 days) (p < 0.0001). The most common adverse events were lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%). There were no serious adverse events. Conclusions: This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention. Trial registration number: NCT02357381

AB - Objective: To evaluate the efficacy and tolerability of single pulse transcranial magnetic stimulation (sTMS) for the preventive treatment of migraine. Background: sTMS was originally developed for the acute treatment of migraine with aura. Open label experience has suggested a preventive benefit. The objective of this trial was to evaluate the efficacy and tolerability of sTMS for migraine prevention. Methods: The e Neura S pringTMS P ost-Market O bservational U.S. S tudy of Migrain e (ESPOUSE) Study was a multicenter, prospective, open label, observational study. From December 2014 to March 2016, patients with migraine (n = 263) were consented to complete a 1-month baseline headache diary followed by 3 months of treatment. The treatment protocol consisted of preventive (four pulses twice daily) and acute (three pulses repeated up to three times for each attack) treatment. Patients reported daily headache status, medication use, and device use with a monthly headache diary. The primary endpoint, mean reduction of headache days compared to baseline, was measured over the 28-day period during weeks 9 to 12. The primary endpoint was compared to a statistically-derived placebo estimate (performance goal). Secondary endpoints included: 50% responder rate, acute headache medication consumption, HIT-6, and mean reduction in total headache days from baseline of any intensity. Results: Of a total of 263 consented subjects, 229 completed a baseline diary, and 220 were found to be eligible based on the number of headache days. The device was assigned to 217 subjects (Safety Data Set) and 132 were included in the intention to treat Full Analysis Set. For the primary endpoint, there was a −2.75 ± 0.40 mean reduction of headache days from baseline (9.06 days) compared to the performance goal (−0.63 days) (p < 0.0001). The 50% responder rate of 46% (95% CI 37%, 56%) was also significantly higher (p < 0.0001) than the performance goal (20%). There was a reduction of −2.93 (5.24) days of acute medication use, headache impact measured by HIT-6, −3.1 (6.4) (p < 0.0001), and total headache days of any intensity −3.16 days (5.21) compared to the performance goal (−0.63 days) (p < 0.0001). The most common adverse events were lightheadedness (3.7%), tingling (3.2%), and tinnitus (3.2%). There were no serious adverse events. Conclusions: This open label study suggests that sTMS may be an effective, well-tolerated treatment option for migraine prevention. Trial registration number: NCT02357381

KW - Migraine

KW - preventive treatment

KW - single-pulse

KW - transcranial magnetic stimulation

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