Repetitive Transcranial Magnetic Stimulation (rTMS) in Fibromyalgia

NCT03909009 | Completed Results

• 1 other identifier: 14032019
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of 10 Hz neuronavigated repetitive transcranial magnetic stimulation (rTMS) to the left dorsolateral prefrontal cortex (DLPFC) on pain, stiffness, fatigue, depression/anxiety, quality of life and cognitive functions in fibromyalgia syndrome (FMS).

Conditions

Fibromyalgia

Keywords

Fibromyalgia, neuronavigated-rTMS, pain, stiffness, fatigue

Outcome Measures

Primary Outcomes (1)

• Visual Analog Scale-Pain

  The severity of the pain at rest was assessed on a 10 cm visual analog scale (Total score: 0-10)(0=no pain, 10=severe pain) Higher scores mean a worse outcome.

  in the second week

Secondary Outcomes (2)

• Visual Analog Scale-Pain

  in the sixth week

• Fibromyalgia Impact Questionnaire

  in the sixth week

Other Outcomes (5)

• Visual Analog Scale-Stiffness

  in the second week

• Fibromyalgia Impact Questionnaire

  in the second week

• Fatigue Severity Scale

  in the sixth week

Study Arms (2)

Active rTMS

ACTIVE COMPARATOR

Group 1 will receive high frequency repetitive transcranial magnetic stimulation (10hz-HF-rTMS) A total 14 sessions of HF-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks).

Device: rTMS + Neuronavigation

Sham rTMS

SHAM COMPARATOR

Group 2 will receive sham stimulation. A total 14 sessions of sham-rTMS, 10 sessions daily (5 days/week, 2 weeks) and 4 sessions weekly (1 day/week, 4 weeks).

Device: rTMS + Neuronavigation

Interventions

rTMS + Neuronavigation DEVICE

Repetitive Transcranial Magnetic Stimulation (Neuro-MS/D) + Neural Navigator

Active rTMS; Sham rTMS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (age between 18-65 years)
• Diagnosis of fibromyalgia syndrome according to 2016 Fibromyalgia diagnostic criteria
• The mean pain intensity is VAS ≥ 4/10
• Stable treatment for at least last 3 months
• Patients accepting participation by signing an informed consent form

You may not qualify if:

• To have a clinical condition to be contraindicated for TMS (metallic implant, cardiac pace, pregnancy, lactation, 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

Sponsors & Collaborators

• Izmir Katip Celebi University: lead

Study Sites (1)

Izmir Katip Çelebi University Faculty of Medicine, Department of Physical Medicine and Rehabilitation

Izmir, 35290, Turkey (Türkiye)

Location

Related Publications (11)

• Rossini PM, Burke D, Chen R, Cohen LG, Daskalakis Z, Di Iorio R, Di Lazzaro V, Ferreri F, Fitzgerald PB, George MS, Hallett M, Lefaucheur JP, Langguth B, Matsumoto H, Miniussi C, Nitsche MA, Pascual-Leone A, Paulus W, Rossi S, Rothwell JC, Siebner HR, Ugawa Y, Walsh V, Ziemann U. Non-invasive electrical and magnetic stimulation of the brain, spinal cord, roots and peripheral nerves: Basic principles and procedures for routine clinical and research application. An updated report from an I.F.C.N. Committee. Clin Neurophysiol. 2015 Jun;126(6):1071-1107. doi: 10.1016/j.clinph.2015.02.001. Epub 2015 Feb 10.

  PMID: 25797650 BACKGROUND

• Klein MM, Treister R, Raij T, Pascual-Leone A, Park L, Nurmikko T, Lenz F, Lefaucheur JP, Lang M, Hallett M, Fox M, Cudkowicz M, Costello A, Carr DB, Ayache SS, Oaklander AL. Transcranial magnetic stimulation of the brain: guidelines for pain treatment research. Pain. 2015 Sep;156(9):1601-1614. doi: 10.1097/j.pain.0000000000000210.

  PMID: 25919472 BACKGROUND

• Knijnik LM, Dussan-Sarria JA, Rozisky JR, Torres IL, Brunoni AR, Fregni F, Caumo W. Repetitive Transcranial Magnetic Stimulation for Fibromyalgia: Systematic Review and Meta-Analysis. Pain Pract. 2016 Mar;16(3):294-304. doi: 10.1111/papr.12276. Epub 2015 Jan 12.

  PMID: 25581213 BACKGROUND

• Hou WH, Wang TY, Kang JH. The effects of add-on non-invasive brain stimulation in fibromyalgia: a meta-analysis and meta-regression of randomized controlled trials. Rheumatology (Oxford). 2016 Aug;55(8):1507-17. doi: 10.1093/rheumatology/kew205. Epub 2016 May 5.

  PMID: 27150193 BACKGROUND

• Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.

  PMID: 25034472 BACKGROUND

• Saltychev M, Laimi K. Effectiveness of repetitive transcranial magnetic stimulation in patients with fibromyalgia: a meta-analysis. Int J Rehabil Res. 2017 Mar;40(1):11-18. doi: 10.1097/MRR.0000000000000207.

  PMID: 27977465 BACKGROUND

• Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.

  PMID: 31901449 BACKGROUND

• Baudic S, Attal N, Mhalla A, Ciampi de Andrade D, Perrot S, Bouhassira D. Unilateral repetitive transcranial magnetic stimulation of the motor cortex does not affect cognition in patients with fibromyalgia. J Psychiatr Res. 2013 Jan;47(1):72-7. doi: 10.1016/j.jpsychires.2012.09.003. Epub 2012 Oct 15.

  PMID: 23079535 BACKGROUND

• Tekin A, Özdil E, Güleken MD, İlişer R, Bakım B, Öncü J, et al. Efficacy of HighFrequency [10 Hz] Repetitive Transcranial Magnetic Stimulation of the PrimaryMotor Cortex in Patients with Fibromyalgia Syndrome: A Randomized, DoubleBlind, Sham-Controlled Trial. Journal of Musculoskeletal Pain. 2014;22(1):20-26.

  BACKGROUND

• Rossi S, Hallett M, Rossini PM, Pascual-Leone A; Safety of TMS Consensus Group. Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research. Clin Neurophysiol. 2009 Dec;120(12):2008-2039. doi: 10.1016/j.clinph.2009.08.016. Epub 2009 Oct 14.

  PMID: 19833552 BACKGROUND

• Bilir I, Askin A, Sengul I, Tosun A. Effects of High-Frequency Neuronavigated Repetitive Transcranial Magnetic Stimulation in Fibromyalgia Syndrome: A Double-Blinded, Randomized Controlled Study. Am J Phys Med Rehabil. 2021 Feb 1;100(2):138-146. doi: 10.1097/PHM.0000000000001536.

  PMID: 32701637 DERIVED

MeSH Terms

Conditions

Fibromyalgia; Pain; Fatigue

Interventions

Transcranial Magnetic Stimulation; Neuronavigation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Surgery, Computer-Assisted; Investigative Techniques

Limitations and Caveats

Current study has several limitations: First is the relatively small sample size. Second, we didn't use sham stimulation probe. Third, our patients only consisted of female gender.

Results Point of Contact

• Title: Doç.Dr. Ayhan AŞKIN
• Organization: Izmir Katip Çelebi University, Faculty of Medicine

ayhanaskin@hotmail.com

00902322444444

Study Officials

• Ayhan Aşkın, Assoc. Prof.

  Izmir Katip Çelebi University Faculty of Medicine

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: April 9, 2019
• Study Start: April 11, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 10, 2020
• Last Updated: June 16, 2020
• Results First Posted: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)