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.

NCT06263972 | Not Yet Recruiting DMC

• 1 other identifier: 0168-21EMC
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Fibromyalgia; Electric Shock

Outcome Measures

Primary Outcomes (4)

• 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)

  3 months

• 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

  3 months

• 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

  3 months

• 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

  3 months

Study Arms (3)

Direct Stimulation of the Primary Motor Cortex (M1) Combined With Aerobic Activity.

ACTIVE COMPARATOR

low current electrical stimulation to Motor cortex for 3 weeks.

Device: Direct Stimulation to Motor Cortex; Behavioral: erobic physical activity

Direct Stimulation the Prefrontal Cortex Combined With Aerobic Activity

ACTIVE COMPARATOR

with low current electrical stimulation to Prefrontal cortex for 3 weeks.

Device: Direct Stimulation Prefrontal Cortex; Behavioral: erobic physical activity

Shame Stimulation Combined With Aerobic Activity

SHAM COMPARATOR

Shame low current electrical stimulation to cortex for 3 weeks.

Device: Shame cortex stimulation; Behavioral: erobic physical activity

Interventions

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.

Direct Stimulation the Prefrontal Cortex Combined With Aerobic Activity

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.

Shame Stimulation Combined With Aerobic Activity

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.

Direct Stimulation of the Primary Motor Cortex (M1) Combined With Aerobic Activity.

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),

Direct Stimulation of the Primary Motor Cortex (M1) Combined With Aerobic Activity.; Direct Stimulation the Prefrontal Cortex Combined With Aerobic Activity; Shame Stimulation Combined With Aerobic Activity

Eligibility Criteria

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

You may qualify if:

• 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.
• Ability to perform aerobic exercise

You may not qualify if:

• Other Causes of pain
• Psychotic disorder
• Severe Depression
• Cognitive disorder
• Drug or alcohol abuse in the last 6 months
• pregnancy

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• Technion, Israel Institute of Technology: collaborator
• Rambam Health Care Campus: collaborator

MeSH Terms

Conditions

Fibromyalgia

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Shahak Yariv

CONTACT

972-4-6495590; yariv_sh@clalit.org.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, Head of neuromodulation

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: February 16, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share