An interventional study of Direct Stimulation Prefrontal Cortex and Shame cortex stimulation in Fibromyalgia and Electric Shock, sponsored by HaEmek Medical Center, Israel. Not yet recruiting. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-16.
Sponsored by HaEmek Medical Center, Israel · Not applicable, Interventional, and Treatment
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.
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.
1,243 studies on the registry are indexed under Fibromyalgia; 256 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 937 interventional studies indexed under Fibromyalgia.
Browse Fibromyalgia studies →HaEmek Medical Center, Israel is the lead sponsor of 237 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
low current electrical stimulation to Motor cortex for 3 weeks.
Device: Direct Stimulation to Motor Cortex · Behavioral: erobic physical activity
with low current electrical stimulation to Prefrontal cortex for 3 weeks.
Device: Direct Stimulation Prefrontal Cortex · Behavioral: erobic physical activity
Shame low current electrical stimulation to cortex for 3 weeks.
Device: Shame cortex stimulation · Behavioral: erobic physical activity
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.
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.
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.
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),
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
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
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
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
No study locations are listed for this record.
Plan to share: No
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HaEmek Medical Center, Israel →