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.

NCT ID: NCT06263972

Last Updated: 2024-02-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-31
• Study Completion Date: 2026-07-31

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.

Detailed Description

Fibromyalgia is a disorder of unknown origin that causes widespread pain, fatigue, sleep disorders, cognitive disorders, depression and anxiety. Today, the treatments for fibromyalgia are limited in their effectiveness in most cases. Previous works have demonstrated that the self-regulation ability among those dealing with fibromyalgia is impaired, and their quality of life is poor.

Therapy using low current electrical stimulation is considered an effective, safe and non-invasive means of treating various disorders including treatment of depression, neurological rehabilitation and various pain syndromes.

A number of works have demonstrated the effectiveness of treating fibromyalgia using stimulation using low electrical current , and it has also been demonstrated that a combination of electrical stimulation with aerobic activity improved the results, together with each of the treatments separately. There are several areas that can be stimulated including the primary motor area (M1) and the prefrontal area , however, the studies performed were limited to a relatively small number of subjects, and no direct comparison was made between the different stimulation locations.

For the study, male and female patients dealing with fibromyalgia will be recruited from the hospital clinics or those who will be referred by the attending physician, or will respond to recruitment notices, in total we intend to recruit 120 participants (40 in each group). The patients will be randomly assigned to real stimulation for each of the areas or to blood stimulation in a ratio of 1:1:1. 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

Study Design

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

Study Groups

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

low current electrical stimulation to Motor cortex for 3 weeks.

Group Type: ACTIVE_COMPARATOR

Direct Stimulation to Motor Cortex

Intervention Type: 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

Intervention Type: 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 the Prefrontal Cortex Combined With Aerobic Activity

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

Group Type: ACTIVE_COMPARATOR

Direct Stimulation Prefrontal Cortex

Intervention Type: 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.

erobic physical activity

Intervention Type: 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),

Shame Stimulation Combined With Aerobic Activity

Shame low current electrical stimulation to cortex for 3 weeks.

Group Type: SHAM_COMPARATOR

Shame cortex stimulation

Intervention Type: 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.

erobic physical activity

Intervention Type: 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),

Interventions

Direct Stimulation Prefrontal Cortex

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.

Intervention Type: DEVICE

Shame cortex stimulation

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.

Intervention Type: DEVICE

Direct Stimulation to Motor Cortex

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.

Intervention Type: DEVICE

erobic physical activity

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),

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

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

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

Sponsors

Technion, Israel Institute of Technology

OTHER

Sponsor Role: collaborator

Rambam Health Care Campus

OTHER

Sponsor Role: collaborator

HaEmek Medical Center, Israel

OTHER

Sponsor Role: lead

Responsible Party

Shahak Yariv

Doctor, Head of neuromodulation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Shahak Yariv

Role: CONTACT

yariv_sh@clalit.org.il

972-4-6495590

Other Identifiers

0168-21EMC

Identifier Type: -

Identifier Source: org_study_id