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Repetitive Transcranial Magnetic Stimulation (rTMS) in Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03909009
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
İbrahim Bilir, Izmir Katip Celebi University

Brief Summary:
Our study was designed as a prospective, randomized, double-blind, sham-controlled parallel group study. We aim to investigate the effectiveness of high frequency (HF) repetitive TMS (rTMS) to the left dorsolateral prefrontal cortex (DLPFC) in fibromyalgia patients.

Condition or disease Intervention/treatment Phase
Fibromyalgia Device: rTMS + Neuronavigation Not Applicable

Detailed Description:

Our study was designed as a prospective, randomized, double-blind, sham-controlled parallel group study. We aim to investigate the effectiveness of high frequency (HF) repetitive TMS to the left dorsolateral prefrontal cortex in fibromyalgia patients.

Twenty patients with fibromyalgia will be randomized into 2 groups. All patients will be evaluated with pain severity (VAS-10mm),stiffness severity (VAS-10mm), Fibromyalgia Impact Questionnaire (FIQ), Fatigue Severity Scale (FSS), Hospital Depression Anxiety Scale (HADS), Addenbrook Cognitive Examination - last revised version (ACE-R) before starting treatment. Patients in Group 1 will receive HF rTMS treatment daily from Monday to Friday in first 2 weeks. After first 2 weeks there will be sessions once a week for 1 month.There will be 14 sessions in total. Sham stimulation will be carried out with the same coil which placed at 90° angles to vertex. Patients in Group 2 will receive sham daily from Monday to Friday in first 2 weeks. After first 2 weeks there will be sessions once a week for 1 month.There will be 14 sham sessions in total.

Patients will be questioned for the safety of treatment. Available drug therapies will be continued in both groups. Patients and clinical raters will be blinded to treatment.All patients will be reviewed by the investigator in terms of rTMS treatment safety and motor threshold determination before each treatment session and observed for possible side effects after treatment.All side effects will be recorded.Magnetic stimulation will be applied using Neurosoft-Neuro MS/D with a figure-of-eight-shaped coil. Stimulation will be made from 90% of the motor threshold.The Stimulation procedure was planned as 5 s 10hz stimulation and 25 second interval period.In real applications, a total of 1500 stimuli per day will be given to each patient.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on Pain, Fatigue, Quality of Life, Cognitive Function and Mood in Fibromyalgia
Actual Study Start Date : April 11, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fibromyalgia

Arm Intervention/treatment
Active Comparator: Active rTMS

Group 1 will receive HF rTMS treatment daily from Monday to Friday in first 2 weeks. After first 2 weeks there will be sessions once a week for 1 month.

There will be 14 sessions in total.

Device: rTMS + Neuronavigation
Repetitive Transcranial Magnetic Stimulation (Neuro-MS/D) + Neural Navigator

Sham Comparator: Sham rTMS

Group 2 will receive sham daily from Monday to Friday in first 2 weeks. After first 2 weeks there will be sessions once a week for 1 month.

There will be 14 sham sessions in total.

Device: rTMS + Neuronavigation
Repetitive Transcranial Magnetic Stimulation (Neuro-MS/D) + Neural Navigator




Primary Outcome Measures :
  1. Change in pain severity (Visual Analog Scale) [ Time Frame: in the second week ]
    Visual Analog Scale (0-10). Higher value means more pain severity.


Secondary Outcome Measures :
  1. Change in pain severity (Visual Analog Scale) [ Time Frame: in the sixth week ]
    Visual Analog Scale (0-10). Higher scores indicate more pain severity.

  2. Change in quality of life (Fibromyalgia Impact Questionnaire) [ Time Frame: in the sixth week ]
    Fibromyalgia Impact Questionnaire (0-100). Higher scores indicate low functionality level.


Other Outcome Measures:
  1. Pain severity (Visual Analog Scale) [ Time Frame: Baseline, week 2, week 6 ]
    Visual Analog Scale (0-10). Higher scores indicate more pain severity.

  2. Stiffness severity (Visual Analog Scale) [ Time Frame: Baseline, week 2, week 6 ]
    Visual Analog Scale (0-10). Higher scores indicate more stiffness severity.

  3. Quality of life (Fibromyalgia Impact Questionnaire) [ Time Frame: Baseline, week 2, week 6 ]
    Fibromyalgia Impact Questionnaire (0-100). Higher scores indicate low functionality level.

  4. Fatigue (Fatigue Severity Scale) [ Time Frame: Baseline, week 2, week 6 ]
    Fatigue Severity Scale (0-7). Higher scores indicate more fatigue severity.

  5. Mood (Hospital Anxiety and Depression Scale) [ Time Frame: Baseline, week 6 ]
    Hospital Anxiety and Depression Scale (0-21). Higher scores indicate mood problems.

  6. Cognitive Function (Addenbrook Cognitive Examination) [ Time Frame: Baseline, week 6 ]
    Addenbrook Cognitive Examination - last revised version. (Total score 0-100)(Subscores: Attention (0-18), Memory (0-26), Fluency (0-14), Language (0-26), Visuospatial (0-16) )



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Woman
  • 18-65 years old
  • Diagnosis of fibromyalgia syndrome according to 2016 Fibromyalgia diagnostic criteria
  • the mean pain intensity is VAS ≥4 / 10
  • The medical treatment of fibromyalgia has been stable for the last 3 months.
  • Patients accepting participation by signing an informed consent form

Exclusion Criteria:

  • To have a clinical condition to be contraindicated for TMS(metallic implant, cardiac pace, pregnancy, lactation, claustrophobia, epilepsy, head trauma, history of cranial operation ..)
  • The presence of malignancy
  • Systemic rheumatic diseases
  • Major orthopedic / neurological problems that limit daily life activities
  • Alcohol or drug addiction
  • Major depression / personality disorder history
  • Have received TMS treatment before
  • Pregnancy or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03909009


Contacts
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Contact: İbrahim Bilir 00905069376917 dribrahimbilir@gmail.com

Locations
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Turkey
Izmir Katip Celebi University Physical Medicine and Rehabilitation Clinic Recruiting
İzmir, Turkey, 35290
Contact: Ayhan AŞKIN, MD    2322444444 ext 1529    ayhanaskin@hotmail.com   
Principal Investigator: İbrahim BİLİR, MD         
Principal Investigator: Ayhan AŞKIN, MD         
Sponsors and Collaborators
Izmir Katip Celebi University
Investigators
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Study Director: Ayhan Aşkın Izmir Katip Celebi University

Publications:

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Responsible Party: İbrahim Bilir, Principal Investigator, Izmir Katip Celebi University
ClinicalTrials.gov Identifier: NCT03909009     History of Changes
Other Study ID Numbers: 14032019
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by İbrahim Bilir, Izmir Katip Celebi University:
Fibromyalgia, transcranial magnetic stimulation, pain

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases