Repetitive Transcranial Magnetic Stimulation (rTMS) in Fibromyalgia

NCT ID: NCT03909009

Last Updated: 2020-06-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-11
• Study Completion Date: 2020-04-10

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).

Detailed Description

This is a single-center, prospective, randomized, double-blind, sham-controlled study in two-arm parallel-group design. Twenty participants will be randomized into 2 groups. Randomization will be performed using computer-generated block randomization with 1:1 allocation between the active rTMS group (Group 1) and the sham-control group (Group 2). 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). 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).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-revised version (ACE-R).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. rTMS therapy will be applied under the guide of neuronavigation with the following parameters: target-left DLPFC, with the %90 of the RMT, 10 Hz stimulation for 5 seconds intervals (on) with 25 seconds inter-train intervals (off), 15 minutes, 1500 pulses.

Conditions

Fibromyalgia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active rTMS

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).

Group Type: ACTIVE_COMPARATOR

rTMS + Neuronavigation

Intervention Type: DEVICE

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

Sham rTMS

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).

Group Type: SHAM_COMPARATOR

rTMS + Neuronavigation

Intervention Type: DEVICE

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

Interventions

rTMS + Neuronavigation

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Izmir Katip Celebi University

OTHER

Sponsor Role: lead

Responsible Party

İbrahim Bilir

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ayhan Aşkın, Assoc. Prof.

Role: STUDY_DIRECTOR

Izmir Katip Çelebi University Faculty of Medicine

Locations

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

Izmir, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

14032019

Identifier Type: -

Identifier Source: org_study_id