UHCDS a-tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients
NCT ID: NCT05726149
Last Updated: 2024-05-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
90 participants
INTERVENTIONAL
2023-03-01
2023-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
UHCDS a-tDCS + TE in Fibromyalgia Patients
NCT06169748
tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients
NCT04050254
TDCS and Tele-rehabilitation Exercise in Fibromyalgia
NCT06616181
Use of Transcranial Direct Current Stimulation (TDCS) in an Active Pain Coping Program for Patients With Fibromyalgia: A Randomized Control Trial.
NCT07239427
Effects of tDCS on People With Fibromyalgia
NCT05266989
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Perhaps this is why its therapeutic approach is refractory to current treatments.
Apart from the widespread chronic pain characteristic of this syndrome, fatigue is a very disabling symptom in this pathology. It is a complicated, multifactorial, disconcerting and very persistent symptom that is highly frequent in FM. A vast majority of the published studies have focused the symptoms studied in FM on pain, while fatigue and sleep disturbances, despite not being minor symptoms, have not received the same attention.
Neuromodulation treatments with transcranial direct current stimulation (tDCS) have been shown to induce significant analgesia in FM through modification of sensory processing of pain by thalamic inhibitory circuits and improvement of sleep architecture. On the other hand, therapeutic exercise (TE) programs based on aerobic work and global muscle strengthening have been shown to have a beneficial effect in reducing the pain and severity of FM.
None of the four studies conducted so far combining tDCS and TE in fibromyalgia have evaluated the effect on fatigue or sleep. Currently, various studies conclude that Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation (UHCDS a-tDCS) on the dorsolateral prefrontal cortex (DLPFC) and M1 produces a 50% greater modulation of corticospinal excitability. To date, no RCT has studied its effect in subjects with FM.
The present study aims to investigate the effect of UHCDS a-tDCS combined with TE on fatigue and sleep quality in subjects with FM.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Real UHCDS a-TDCS + Therapeutic Exercise
Real unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise
Real UHCDS a-tDCS
Real UHCDS a-tDCS (STARTSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for ten sessions (three sessions per week in weeks 1 and 2; and one session per week in weeks 3, 4, 5 and 6). UHCDS a-tDCS is a galvanic current applied by a cap for 20 minutes at an intensity of 2 milliamps.
Therapeutic exercise
The therapeutic exercise program will include aerobic exercise and muscle strengthening in the same days as UHCDS a-tDCS. The program will last 30-45 minutes.
Sham UHCDS a-TDCS + Therapeutic Exercise
Sham unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise
Therapeutic exercise
The therapeutic exercise program will include aerobic exercise and muscle strengthening in the same days as UHCDS a-tDCS. The program will last 30-45 minutes.
Sham UHCDS a-tDCS
Sham UHCDS a-tDCS (STARSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for ten sessions (three sessions per week in weeks 1 and 2; and one session per week in weeks 3, 4, 5 and 6). Sham tDCS will be applied for the same time than real UHCDS a-tDCS.
Therapeutic Exercise
Therapeutic exercise.
Therapeutic exercise
The therapeutic exercise program will include aerobic exercise and muscle strengthening in the same days as UHCDS a-tDCS. The program will last 30-45 minutes.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Real UHCDS a-tDCS
Real UHCDS a-tDCS (STARTSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for ten sessions (three sessions per week in weeks 1 and 2; and one session per week in weeks 3, 4, 5 and 6). UHCDS a-tDCS is a galvanic current applied by a cap for 20 minutes at an intensity of 2 milliamps.
Therapeutic exercise
The therapeutic exercise program will include aerobic exercise and muscle strengthening in the same days as UHCDS a-tDCS. The program will last 30-45 minutes.
Sham UHCDS a-tDCS
Sham UHCDS a-tDCS (STARSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for ten sessions (three sessions per week in weeks 1 and 2; and one session per week in weeks 3, 4, 5 and 6). Sham tDCS will be applied for the same time than real UHCDS a-tDCS.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
* Able to participated in a therapeutic exercise program.
* Understanding of spoken and written Spanish.
Exclusion Criteria
* Metallic implants in the head.
* Tumor, trauma or surgery in the brain.
* Epilepsy or stroke.
* History of substance abuse in the last 6 months.
* Use of carbamazepine in the last 6 months.
* Diagnosed psychiatric pathology.
* Rheumatic pathology not medically controlled.
* Coexisting autoimmune pathology.
* Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Castilla-La Mancha
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hospital Nuestra Señora del Prado
Talavera de la Reina, Toledo, Spain
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UHCDSa-tDCS+EX-Fibromyalgia
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.