Studying Efficacy of dTMS in FMNCT03460340
dTMS as a Treatment for Patients With Fibromyalgia
A study testing prefrontal deep rTMS of H1 Coil in people with Studying Efficacy of dTMS in FM, run by Shalvata Mental Health Center.
Trial summary
Purpose: The purpose of the study is to explore the efficacy of H1 deep TMS for the treatment of FMS. Design: Prospective randomized sham controlled trial Study Population \& sample size:forty (40) FMS subjects between 18-80 years of age. No. of Centers: Four centers- 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Studying Efficacy of dTMS in FM
- What is being tested?
- prefrontal deep rTMS of H1 Coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Apr 2018to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-80 years.
- Patients who continue to take their administered medications or patients who stopped ineffective administered medications
- Concomitant medication for pain and sleep disorders will be allowed provided the dose administered had been stable for at least 2 weeks before enrollment and remains stable throughout the study.
- Gave informed consent for participation in the study.
Who cannot join
- Subjects will be excluded if evidence is found of inflammatory rheumatic disease, autoimmune disease, or other painful disorders that might confound assessment of FMS pain.
- Subjects diagnosed with a current primary (Axis I) psychiatric condition according to Diagnostic and Statistical Manual of Mental Disorders-IV criteria, including anxiety disorders, not including major depression or major personality disorder. Subject with a history of substance abuse and pregnant women will be excluded as well.
- History of any metal in the head (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
- History of head injury.
- History of seizure or heat convulsion.
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- History of epilepsy or seizure in first degree relatives.
- History of frequent or severe headaches.
- Use of hearing aids for hearing loss.
- Known history of cochlear implants.
- History of drug abuse or alcoholism during the last year.
- Serious and unstable medical condition, which is likely to exacerbate or endanger the patient during the treatment period.
- Significant difficulties in language or communication.
- Subjects declared as legally incompetent, with an appointed physical guardian and/or cannot sign informed consent due to cognitive incompetence.
- Participation in current clinical study or clinical study within 30 days prior to this study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Randomized Sham-controlled Study of Deep Transcranial Magnetic Stimulation (dTMS) as a Treatment for Patients With Fibromyalgia
Purpose: The purpose of the study is to explore the efficacy of H1 deep TMS for the treatment of FMS.
Design: Prospective randomized sham controlled trial Study Population \& sample size:forty (40) FMS subjects between 18-80 years of age.
Read more
No. of Centers: Four centers-
- Shalvata Mental Health Center, Tel -Aviv University, Israel.
- Soraski medical center, Tel-Aviv University, Israel.
- Sheba Medical Center, Tel-Aviv University, Israel
- Beer-Yakov Mental Health Center, Tel-Aviv University, Israel. Duration and intensity of Treatment: All subjects will receive prefrontal deep rTMS of H1 Coil (75 trains of 2 seconds, 20 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold, a total of 3000 pulses per session), for 4 weeks, 5 days a week, overall 20 sessions.
Name of device: The Brainsway Ltd. H1-Coil
Study Endpoints: Clinical outcome:
primary outcome Change in self-reported average pain intensity over the last 24 hours will be measured at the end point with the numerical scale (0 = no pain, 10 = maximal pain imaginable) of the VAS-FIQ.
secondary outcome
- Change of sensory and affective pain dimensions will be measured at the end point using the McGill Pain Questionnaire.
- Change of the impact of pain and FMS on quality of life, will be measured at the end point using the BPI items for pain interference.
- change of sensitivity to painful stimuli will be evaluated by physical measurements:
- WPI
- SSS
- Changes in cognitive functions in domains of attention, working memory, spatial memory, executive functions and social cognition will be measured at the beginning and end point of the study using the Penn Web-Based Computerized Neurocognitive Battery (WebCNP).
- Conditions
- Studying Efficacy of dTMS in FM
- Being tested
- prefrontal deep rTMS of H1 Coil
- Keywords
- dTMS, Fibromyalgia
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prefrontal deep rTMS of H1 CoilDevice
prefrontal deep rTMS of H1 Coil
| Study group | Role | What they receive |
|---|---|---|
| FM group | Experimental | patients diagnosed with Fibromyalgia receiving dTMS treatment. Receives: Device: prefrontal deep rTMS of H1 Coil |
| placebo group | Sham comparator | patients diagnosed with Fibromyalgia receiving sham- treatment. Receives: Device: prefrontal deep rTMS of H1 Coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in self-reported average pain intensity over the last 24 hours
self-reported average pain intensity over the last 24 hours will be measured with numerical scale (0 = no pain, 10 = maximal pain imaginable) of the VAS-FIQ- self-reported average pain intensity scale
Measured: at the beginning of each session, before stimulation (Subjects will undergo 5 courses per week for 4 weeks)
Secondary outcomes (3)
Change of sensory and affective pain dimensions
Change of sensory and affective pain dimensions -using the McGill Pain Questionnaire (16 items rated between 0 "not at all" - 3 "very strong")
Measured: at baseline, once a week during trial period (4 weeks), and at follow-up visit (2 weeks after the end of the treatments)
Change of the impact of pain and FMS on quality of life
Change of the impact of pain and FMS on quality of life- using the BPI- items rated between 1 "functioning as usual" to 10 "very affected by the pain")
Measured: at baseline, once a week during trial period (4 weeks), and at follow-up visit (2 weeks after the end of the treatments)
Changes in cognitive functions in domains of attention, working memory, spatial memory, executive functions and social cognition
Changes in cognitive functions in domains of attention, working memory, spatial memory, executive functions and social cognition - using the the Penn Web-Based Computerized Neurocognitive Battery (WebCNP).
Measured: baseline and end point (after 4 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study startApr 2018 (estimated)
- Primary completionApr 2019 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Studying Efficacy of dTMS in FMStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized control trial (RCT)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shalvata Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460340
- Sponsor's protocol ID
- SHA-17-18
- Status last verified
- Mar 2018
- First submitted
- 4 Feb 2018
- Last updated
- 9 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided: no IPD planned to be shared at this moment
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Sham-controlled Study of Deep Transcranial Magnetic Stimulation (dTMS) as a Treatment for Patients With Fibromyalgia
- ClinicalTrials.gov ID
- NCT03460340
- Acronym / sponsor ID
- SHA-17-18
- Conditions
- Studying Efficacy of dTMS in FM
- Keywords
- dTMS, Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shalvata Mental Health CenterUniversity, hospital or other
- Study start
- Apr 2018 (estimated)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 9 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The purpose of the study is to explore the efficacy of H1 deep TMS for the treatment of FMS.
Design: Prospective randomized sham controlled trial Study Population \& sample size:forty (40) FMS subjects between 18-80 years of age.
No. of Centers: Four centers-
- Shalvata Mental Health Center, Tel -Aviv University, Israel.
- Soraski medical center, Tel-Aviv University, Israel.
- Sheba Medical Center, Tel-Aviv University, Israel
- Beer-Yakov Mental Health Center, Tel-Aviv University, Israel. Duration and intensity of Treatment: All subjects will receive prefrontal deep rTMS of H1 Coil (75 trains of 2 seconds, 20 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold, a total of 3000 pulses per session), for 4 weeks, 5 days a week, overall 20 sessions.
Name of device: The Brainsway Ltd. H1-Coil
Study Endpoints: Clinical outcome:
primary outcome Change in self-reported average pain intensity over the last 24 hours will be measured at the end point with the numerical scale (0 = no pain, 10 = maximal pain imaginable) of the VAS-FIQ.
secondary outcome
- Change of sensory and affective pain dimensions will be measured at the end point using the McGill Pain Questionnaire.
- Change of the impact of pain and FMS on quality of life, will be measured at the end point using the BPI items for pain interference.
- change of sensitivity to painful stimuli will be evaluated by physical measurements:
- WPI
- SSS
- Changes in cognitive functions in domains of attention, working memory, spatial memory, executive functions and social cognition will be measured at the beginning and end point of the study using the Penn Web-Based Computerized Neurocognitive Battery (WebCNP).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized control trial (RCT)
| Arm | Type | Receives |
|---|---|---|
| FM group | Experimental | Device: prefrontal deep rTMS of H1 Coilpatients diagnosed with Fibromyalgia receiving dTMS treatment. |
| placebo group | Sham comparator | Device: prefrontal deep rTMS of H1 Coilpatients diagnosed with Fibromyalgia receiving sham- treatment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18-80 years.
- Patients who continue to take their administered medications or patients who stopped ineffective administered medications
- Concomitant medication for pain and sleep disorders will be allowed provided the dose administered had been stable for at least 2 weeks before enrollment and remains stable throughout the study.
- Gave informed consent for participation in the study.
Key exclusion criteria (15 listed)
- Subjects will be excluded if evidence is found of inflammatory rheumatic disease, autoimmune disease, or other painful disorders that might confound assessment of FMS pain.
- Subjects diagnosed with a current primary (Axis I) psychiatric condition according to Diagnostic and Statistical Manual of Mental Disorders-IV criteria, including anxiety disorders, not including major depression or major personality disorder. Subject with a history of substance abuse and pregnant women will be excluded as well.
- History of any metal in the head (outside the mouth).
- Known history of any metallic particles in the eye, implanted cardiac pacemaker or any intracardiac lines, implanted neurostimulators, surgical clips or any medical pumps.
- History of head injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prefrontal deep rTMS of H1 Coilprefrontal deep rTMS of H1 Coil | Device | FM group, placebo group |
Primary outcome
change in self-reported average pain intensity over the last 24 hours
Time frame: at the beginning of each session, before stimulation (Subjects will undergo 5 courses per week for 4 weeks)
self-reported average pain intensity over the last 24 hours will be measured with numerical scale (0 = no pain, 10 = maximal pain imaginable) of the VAS-FIQ- self-reported average pain intensity scale
3 secondary outcomes
Change of sensory and affective pain dimensions
Time frame: at baseline, once a week during trial period (4 weeks), and at follow-up visit (2 weeks after the end of the treatments)
Change of the impact of pain and FMS on quality of life
Time frame: at baseline, once a week during trial period (4 weeks), and at follow-up visit (2 weeks after the end of the treatments)
Changes in cognitive functions in domains of attention, working memory, spatial memory, executive functions and social cognition
Time frame: baseline and end point (after 4 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2018.
- Individual participant dataSharing planned: Undecided. no IPD planned to be shared at this moment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing prefrontal deep rTMS of H1 Coil in people with Studying Efficacy of dTMS in FM, run by Shalvata Mental Health Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uri Nitzan, MD (09-7478644, urini@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in self-reported average pain intensity over the last 24 hours (time frame: at the beginning of each session, before stimulation (Subjects will undergo 5 courses per week for 4 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2018.