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.

HaEmek Medical Center, Israel

Status: Not yet enrolling

Conditions: Fibromyalgia; Electric Shock

Treatments: Device: Shame cortex stimulation; Device: Direct Stimulation to Motor Cortex; Device: Direct Stimulation Prefrontal Cortex; Behavioral: erobic physical activity

Study type: Interventional

Funder types: Other

Identifiers

NCT06263972

0168-21EMC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups

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

Active Comparator group

Description:

low current electrical stimulation to Motor cortex for 3 weeks.

Treatment:

Device: Direct Stimulation to Motor Cortex

Behavioral: erobic physical activity

Direct Stimulation the Prefrontal Cortex Combined With Aerobic Activity

Active Comparator group

Description:

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

Treatment:

Device: Direct Stimulation Prefrontal Cortex

Behavioral: erobic physical activity

Shame Stimulation Combined With Aerobic Activity

Sham Comparator group

Description:

Shame low current electrical stimulation to cortex for 3 weeks.

Treatment:

Device: Shame cortex stimulation

Behavioral: erobic physical activity