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Botox Vs Spinal Cord Stimulation in the Treatment of Refractory Migraine Clinical Trial (BTX/SCS/TMig)

Primary Purpose

Migraine

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SCS
SCS
Sponsored by
Europainclinics z.ú.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • migraine presence

Exclusion Criteria:

  • disagreement with participation in the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm 7

    Arm 8

    Arm Type

    Experimental

    Experimental

    Placebo Comparator

    Placebo Comparator

    Experimental

    Experimental

    Placebo Comparator

    Placebo Comparator

    Arm Label

    A1 Group SCS

    A1 Group Botox

    B1 Group SCS

    B1 Group Saline

    A2 Group SCS

    A2 Group Botox -after washout period

    B2 Group SCS

    B2 Group Saline -after washout period

    Arm Description

    Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting two weeks after the SCS implant

    Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting two weeks after the SCS implant

    Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting two weeks after the SCS implant

    Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting two weeks after the SCS implant

    Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting at the 28th week of clinical trial investigation

    Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting at the 28th week of clinical trial investigation

    Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting at the 28th week of clinical trial investigation

    Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting at the 28th week of clinical trial investigation

    Outcomes

    Primary Outcome Measures

    Health Questionnaire (EQ-5D-5L)
    1 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems
    Health Questionnaire (EQ-5D-5L)
    Week 13 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems
    Health Questionnaire (EQ-5D-5L)
    Week 25 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems
    Health Questionnaire (EQ-5D-5L)
    Week 28 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems
    Health Questionnaire (EQ-5D-5L)
    Week 40 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems
    Health Questionnaire (EQ-5D-5L)
    Week 52

    Secondary Outcome Measures

    Visual numeric scale
    Type of migraine
    Aura presence
    Duration of the migraine episode

    Full Information

    First Posted
    May 4, 2022
    Last Updated
    May 17, 2022
    Sponsor
    Europainclinics z.ú.
    Collaborators
    National Hospital for Neurology and Neurosurgery, London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05382832
    Brief Title
    Botox Vs Spinal Cord Stimulation in the Treatment of Refractory Migraine Clinical Trial
    Acronym
    BTX/SCS/TMig
    Official Title
    Botox Vs Spinal Cord Stimulation in the Treatment of Refractory Migraine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2022 (Anticipated)
    Primary Completion Date
    August 1, 2022 (Anticipated)
    Study Completion Date
    August 1, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Europainclinics z.ú.
    Collaborators
    National Hospital for Neurology and Neurosurgery, London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The clinical trial is focused on the treatment of selected patients with a migraine after implantation of spinal cord stimulator (SCS) based on previous neurological examination. Patients will be randomized and divided into two groups. According to randomization patients will receive saline or botox into the epidural space. The efficacy of treatment will be compared and estimated in both groups during different SCS settings. Data will be collected in pre-set time frames.
    Detailed Description
    This study consists of a double-blind randomized cross-over controlled trial (RCT). Enrolled centers are National Hospital For Neurology and Neurosurgery in London in the United Kingdom, EuroPainClinics® with centers in Bratislava, Košice, and Bardejov in the Slovac republic and also EuroPainClinics® with centers Praha, Brno, Ostrava, and Hradec Kralove in the Czech republic. Patients with diagnosing migraine (examined previously by neurologist) suitable for participating in the clinical trial, without any previous Botulinum Toxin treatment or Spinal Cord Stimulation therapy, (after exact consultation by neuromodulation team) will be offered to enroll in the BoStiM trial. Enrolled patients will have a full implant of Nevro Senza SCS system. The intervention will be performed at the National Hospital for Neurology and Neurosurgery in London in the United Kingdom, and also in st. Michal Hospital in Bratislava in the Slovak Republic and General University Hospital in Prague in the Czech Republic. The procedure will be performed by the Neuromodulation Team. The implanted SCS will be turned off at this stage and will stay off for 2 weeks' time to let the wounds heal properly and not interfere with headache measurements. Once enrolled in the study, the patients will be randomized into one of the two groups of study. Groups will consist in either first SCS treatment, then washout period, then Botox treatment or SCS, then washout, then Botox. All patients will therefore be their own controls, and all of them will receive both treatments. After randomization, patients will be added to the SCS pathway. During the period between enrolment and SCS implant, patients will have the opportunity to meet the psychology team at the Pain Management Centre (PMC) and will undergo teaching sessions to learn the basic SCS practical aspects. Blinding technique: In order to have a double-blinded RCT, the investigators will not be aware of the trial branch of the participants. Injections will be performed either with Botulinum Toxin or with Normal Saline and Spinal Cord Stimulators will be configured in order to use high-frequency stimulation or a sham treatment. All Internal Pulse Generators (IPG) will be turned on throughout the trial so as to avoid the participants being able to know the treatment they're really receiving at that time. Participants receiving Botox injections will have their IPG running with a sham configuration. They will not be receiving any electric stimulation over the leads, but the battery will be programmed to have a current leakage and will need to be recharged so as if the IPG was properly working. This again is to avoid them knowing which treatment they're receiving at any time being. The Clinical Specialist Nurses (CNS) of our PMC will be in charge of labeling the Botox/Placebo vials, which will be anonymized, and they will also be in charge of setting up the SCS (sham or treatment). Data collection: The enrolled patients will be provided a Smartphone to assess the migraine episodes. Each Smartphone will have an in-built app that the patients will use daily, and that will send the results to the research team. Those patients preferring to use their own smartphone will need to download the app to their smartphone. The app will include a visual numeric scale (VNS) that the participants will need to fulfill daily, as well as qualitative questions including the type of migraine, the onset, presence or absence of aura, duration of the episode, and possible medication intake. The first period of trial: The proper trial period will start two weeks after the implant (week 1). On this day, patients will be invited to come to the PMC. Depending on the randomization group, patients will have either a Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode or a placebo injection and the IPG turned on in proper working mode. Patients will be given a controller for the IPG so that they may be able to turn it off in case of an emergency. They will nonetheless not be able to change the program. None of the investigators will be aware of the group. At week 12, participants will have a new injection of either Botox or Placebo and will be reviewed by the CNS and Nevro team to assess any problems. At that time, they will also be asked to complete through the Smartphone app the Quality of Life (QoL) questionnaires and will be asked to guess their branch. Washout period: At week 24, all participants will undergo a washout period of 1 month. They will be invited to come to the PMC and IPG (both sham and treatment) will be turned off. They will also be asked to fill the QoL questionnaires. Second Period of Trial: At week 28, participants will be invited to come to the PMC and they will start the second part of the trial, being assigned to the other branch. All IPG's will be turned on, those previously being actively treating will be turned to the sham mode and the opposite will be done with previously sham mode ones. Patients previously receiving placebo injections will receive a Botox injection on that day, and those previously receiving Botox injections will receive a placebo one. Quality of life questionnaires will be filled. At week 40, participants will undergo the 4th and last series of injections (Botox or placebo) and will have an assessment with CNS and Nevro team, and will be asked to fill in the usual questionnaires. End of trial: The trial will end at week 52 when patients will be asked to fill in the usual questionnaires. At that moment, they will be communicated to which branch they had been assigned. Patients will then decide whether they want to keep the SCS system or prefer it removed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Migraine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Model Description
    Double-Blinded, Randomized, Controlled Trial
    Masking
    ParticipantInvestigator
    Masking Description
    In order to have a double-blinded RCT, the investigators will not be aware of the trial branch of the participants. Injections will be performed either with Botulinum Toxin or with Normal Saline and Spinal Cord Stimulators will be configured in order to use high-frequency stimulation or a sham treatment.
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    A1 Group SCS
    Arm Type
    Experimental
    Arm Description
    Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting two weeks after the SCS implant
    Arm Title
    A1 Group Botox
    Arm Type
    Experimental
    Arm Description
    Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting two weeks after the SCS implant
    Arm Title
    B1 Group SCS
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting two weeks after the SCS implant
    Arm Title
    B1 Group Saline
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting two weeks after the SCS implant
    Arm Title
    A2 Group SCS
    Arm Type
    Experimental
    Arm Description
    Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting at the 28th week of clinical trial investigation
    Arm Title
    A2 Group Botox -after washout period
    Arm Type
    Experimental
    Arm Description
    Botox Injection and the SCS Internal Pulse Generator turned on in sham-mode. Starting at the 28th week of clinical trial investigation
    Arm Title
    B2 Group SCS
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting at the 28th week of clinical trial investigation
    Arm Title
    B2 Group Saline -after washout period
    Arm Type
    Placebo Comparator
    Arm Description
    Placebo Injection and Internal Pulse Generator turned on in the high-frequency working mode. Starting at the 28th week of clinical trial investigation
    Intervention Type
    Combination Product
    Intervention Name(s)
    SCS
    Other Intervention Name(s)
    Botox
    Intervention Description
    SCS-experimental treatment
    Intervention Type
    Combination Product
    Intervention Name(s)
    SCS
    Other Intervention Name(s)
    Saline
    Intervention Description
    SCS-placebo
    Primary Outcome Measure Information:
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    1 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems
    Time Frame
    14 days after the SCS implant
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    Week 13 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems
    Time Frame
    91 days after the SCS implant
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    Week 25 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems
    Time Frame
    175 days after the SCS implant
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    Week 28 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems
    Time Frame
    196 days after the SCS implant
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    Week 40 Graded from 1-5, where 1 means no problems in the area and 5 meaning extreme problems
    Time Frame
    280 days after the SCS implant
    Title
    Health Questionnaire (EQ-5D-5L)
    Description
    Week 52
    Time Frame
    364 dayss after the SCS implant
    Secondary Outcome Measure Information:
    Title
    Visual numeric scale
    Time Frame
    daily up to 10 days
    Title
    Type of migraine
    Time Frame
    up to 1 week
    Title
    Aura presence
    Time Frame
    up to 1 week
    Title
    Duration of the migraine episode
    Time Frame
    up to 1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: migraine presence Exclusion Criteria: disagreement with participation in the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ashish Shetty, MD, FRCA, FFPMRCA
    Phone
    +447723309217
    Email
    drashshetty@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Nicolas Varela, MD, DESA
    Phone
    +447723309217
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Róbert Rapcan, MD, PhD, MBA, FIPP
    Organizational Affiliation
    EuroPainClincs
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Ladislav Kočan, MD, PhD
    Organizational Affiliation
    EuroPainClincs
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Botox Vs Spinal Cord Stimulation in the Treatment of Refractory Migraine Clinical Trial

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