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Comparison of the Efficacy of Transcranial Direct Current Stimulation (tDCS) of the Primary Motor Cortex (M1) or the Prefrontal Cortex Combined With Aerobic Activity for Alleviation of Fibromyalgia Symptoms.

ConditionsFibromyalgiaElectric Shock
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHaEmek Medical Center, Israel

About this trial

The goal of this study is to demonstrate the effectiveness of treating fibromyalgia using combination of electrical stimulation with aerobic activity.

Participants will be randomly assigned to stimulation in a ratio of 1:1:1. 120 participants (40 in each group). The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation for 3 weeks.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed Fibromyalgia

Pain scale level of 4 or higher

Fail to achieve adequate pain relief with Fibromyalgia treatments

stable Fibromyalgia treatment for at least 4 weeks.

Disqualifiers

Other Causes of pain

Psychotic disorder

Severe Depression

Cognitive disorder

Trial design

Design model

Parallel

Treatments tested in this trial

  • Direct Stimulation Prefrontal Cortex

    Device

    The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation to prefrontal cortex for 3 weeks.

  • Shame cortex stimulation

    Device

    The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with shame low current electrical stimulation to cortex for 3 weeks.

  • Direct Stimulation to Motor Cortex

    Device

    The therapeutic course will include moderate aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment), along with low current electrical stimulation to Motor cortex for 3 weeks.

  • erobic physical activity

    Behavioral

    Aerobic physical activity (at 60% of the target heart rate adjusted for age) 3 times a week for 4 weeks (a week of adjustment, and 3 weeks of treatment),

Treatment groups

120 Participants
are divided into 3 treatment groups
Group A: Direct Stimulation of the Primary Motor Cortex (M1) Combined With Aerobic Activity.Active comparator 2 interventions
Group B: Direct Stimulation the Prefrontal Cortex Combined With Aerobic ActivityActive comparator 2 interventions
Group C: Shame Stimulation Combined With Aerobic ActivitySham comparator 2 interventions

Trial outcomes

Primary outcomes

1

Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas Numeric pain rating scale.

Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation to blood stimulation. Based on: Numeric pain rating scale (score range from 1 to 10)

Time frame
3 months
2

Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation Adult sensory profile test Raw score.

Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation to blood stimulation. Based on: Adult sensory profile test Raw score

Time frame
3 months
3

Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas and in relation to The Montreal Cognitive Assessment (MoCA) score.

Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation to The Montreal Cognitive Assessment (MoCA) score. Based on: The Montreal Cognitive Assessment (MoCA) score

Time frame
3 months
4

Study objectives: • Comparing the effectiveness of direct electric current stimulation between the two stimulus areas and in relation to Generalized Anxiety Disorder 7-Item Scale

Study objectives: • Comparing the effectiveness of direct electric current stimulation (tDCS) between the two stimulus areas and in relation to blood stimulation. Based on: The Generalized Anxiety Disorder 7-Item Scale

Time frame
3 months

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

HaEmek Medical Center, Israel

Lead sponsor

Technion, Israel Institute of Technology

Collaborator

Rambam Health Care Campus

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: