NCT03568617

Brief Summary

We design this pilot, single arm study to explore the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for the treatment of chronic migraine. The hypothetical control group is pooled sham group in latest meta-analysis. We expect a significant improvement of the outcome measures during and after the treatment as compared to the hypothetical control group.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 4, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
4 days until next milestone

Study Start

First participant enrolled

June 30, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

3.5 years

First QC Date

June 4, 2018

Last Update Submit

June 22, 2018

Conditions

Chronic Migraine

Keywords

Transcranial Magnetic StimulationMigraine DisordersProphylaxisTreatment OutcomeBrain

Outcome Measures

Primary Outcomes (1)

  • 50% reduction in the Number of Days with Headache

    A Headache day is defined as a day with a headache that lasts at least 4 hours.

    at 4 weeks

Secondary Outcomes (8)

  • 50% reduction in the Number of Migraine Days

    at 4 weeks

  • 50% reduction in the Number of Moderate/Severe Headache Days

    at 4 weeks

  • Conversion to episodic migraine

    at 4 weeks

  • The Subject's Global Impression of Change (SGIC)

    at 4 weeks

  • Change from Baseline HALT-28 (Headache-Attributed Lost Time - 28 days)

    at baseline and 4 weeks

  • +3 more secondary outcomes

Study Arms (1)

rTMS group

EXPERIMENTAL
Device: rTMS

Interventions

rTMSDEVICE

The subjects will receive 20 trains of 100 stimuli each delivered at 10 Hz and 80% of MT over the left MC (M1), 3 days a week, for 4 weeks.

rTMS group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects meeting the diagnostic criteria for chronic migraine according to the International Classification of Headache Disorders, 3rd edition.
  • The duration of chronic migraine ≥ 6 months.
  • age range of 18 - 65 years old

You may not qualify if:

  • Secondary headaches except MOH
  • any change of the prophylaxis or the analgesic drug strategy during the baseline and follow-up period
  • structural brain lesions
  • seizures
  • severe systemic disease
  • TMS contraindications (such as metal implants)
  • psychosis
  • severe depression or anxiety
  • drug or alcohol dependence
  • pregnancy
  • participating in other experiments at the same time

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Lan L, Zhang X, Li X, Rong X, Peng Y. The efficacy of transcranial magnetic stimulation on migraine: a meta-analysis of randomized controlled trails. J Headache Pain. 2017 Aug 22;18(1):86. doi: 10.1186/s10194-017-0792-4.

    PMID: 28831756BACKGROUND

  • Shehata HS, Esmail EH, Abdelalim A, El-Jaafary S, Elmazny A, Sabbah A, Shalaby NM. Repetitive transcranial magnetic stimulation versus botulinum toxin injection in chronic migraine prophylaxis: a pilot randomized trial. J Pain Res. 2016 Oct 7;9:771-777. doi: 10.2147/JPR.S116671. eCollection 2016.

    PMID: 27785091BACKGROUND

  • Tassorelli C, Diener HC, Dodick DW, Silberstein SD, Lipton RB, Ashina M, Becker WJ, Ferrari MD, Goadsby PJ, Pozo-Rosich P, Wang SJ; International Headache Society Clinical Trials Standing Committee. Guidelines of the International Headache Society for controlled trials of preventive treatment of chronic migraine in adults. Cephalalgia. 2018 Apr;38(5):815-832. doi: 10.1177/0333102418758283. Epub 2018 Mar 4.

    PMID: 29504482BACKGROUND

  • Steiner TJ, Lipton RB; Lifting The Burden: The Global Campaign against Headache. The Headache-Attributed Lost Time (HALT) Indices: measures of burden for clinical management and population-based research. J Headache Pain. 2018 Feb 2;19(1):12. doi: 10.1186/s10194-018-0837-3.

    PMID: 29396646BACKGROUND

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Central Study Contacts

Yuzhou Guan, MD

CONTACT

8613910081750guanyz001@163.com

Hang Shen, MD

CONTACT

8613910131204shenhang12@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 4, 2018

First Posted

June 26, 2018

Study Start

June 30, 2018

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

June 26, 2018

Record last verified: 2018-06