FibromyalgiaNCT05726149
UHCDS a-tDCS Combined With Therapeutic Exercise in Fibromyalgia Patients
A study testing Real UHCDS a-tDCS and Therapeutic exercise in people with Fibromyalgia, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The purpose of this study is to assess the effects on fatigue and sleep of Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation combined with therapeutic exercise in Fibromyalgia patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Real UHCDS a-tDCS and Therapeutic exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2023to 30 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 65 years.
- Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
- Able to participated in a therapeutic exercise program.
- Understanding of spoken and written Spanish.
Who cannot join
- Pregnancy or breastfeeding.
- 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.
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- Diagnosed psychiatric pathology.
- Rheumatic pathology not medically controlled.
- Coexisting autoimmune pathology.
- Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).
Trial locations and contacts
1 site in 1 country.
Spain1 site
Hospital Nuestra Señora del Prado
Talavera de la Reina, Toledo, 45600
About this study
Official title: Efficacy of Unihemispheric Concurrent Dual-Site Anodal Transcranial Direct Current Stimulation Combined With Therapeutic Exercise on Fatigue and Sleep in Fibromyalgia. Randomized Controlled Clinical Trial
The purpose of this study is to assess the effects on fatigue and sleep of Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation combined with therapeutic exercise in Fibromyalgia patients.
Read the detailed description
Fibromyalgia (FM) is one of the rheumatic diseases with the greatest impact on the quality of life, whose etiology and pathophysiology is not yet fully demonstrated.
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
- Fibromyalgia
- Being tested
- Real UHCDS a-tDCS, Therapeutic exercise, Sham UHCDS a-tDCS
- Keywords
- Neuromodulation, Therapeutic exercise, Fatigue, Sleep
- Medical subject headings
- Fibromyalgia, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real UHCDS a-tDCSDevice
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 exerciseDevice
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-tDCSDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Real UHCDS a-TDCS + Therapeutic Exercise | Experimental | Real unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise Receives: Device: Real UHCDS a-tDCS; Device: Therapeutic exercise |
| Sham UHCDS a-TDCS + Therapeutic Exercise | Sham comparator | Sham unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise Receives: Device: Therapeutic exercise; Device: Sham UHCDS a-tDCS |
| Therapeutic Exercise | Active comparator | Therapeutic exercise. Receives: Device: Therapeutic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue from baseline to post-treatment as assessed by MFI.
The version adapted to Spanish from the Multidimensional Fatigue Inventory (MFI) will be used. The scale ranges from 0 to 100. Higher values represent a worse result.
Measured: Baseline; immediately after intervention; 1-month after intervention
Change in sleep quality from baseline to post-treatment as assessed by MOS-SS.
The version adapted to Spanish from the Medical Outcomes Study Sleep Scale (MOS-SS) will be used. The scale ranges from 0 to 100. Higher values represent a worse result.
Measured: Baseline; immediately after intervention; 1-month after intervention
Secondary outcomes (2)
Fibromyalgia Impact Quality-of-Life
It will be measured with the version adapted to the Spanish of the Fibromyalgia Impact Questionnaire (FIQ). The scale ranges from 0 to 100. Higher values represent a worse result.
Measured: Baseline; immediately after intervention; 1-month after intervention
Blinding
Blinding of subjects and researchers will be assessed using the James Index.
Measured: Immediately after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start1 Mar 2023
- Primary completion15 Nov 2023
- Study completion30 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05726149
- Sponsor's protocol ID
- UHCDSa-tDCS+EX-Fibromyalgia
- Status last verified
- May 2024
- First submitted
- 26 Jan 2023
- Last updated
- 28 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Unihemispheric Concurrent Dual-Site Anodal Transcranial Direct Current Stimulation Combined With Therapeutic Exercise on Fatigue and Sleep in Fibromyalgia. Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05726149
- Acronym / sponsor ID
- UHCDSa-tDCS+EX-Fibromyalgia
- Conditions
- Fibromyalgia
- Keywords
- Neuromodulation, Therapeutic exercise, Fatigue, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 15 Nov 2023 (actual)
- Study completion
- 30 Nov 2023 (actual)
- First posted
- 13 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effects on fatigue and sleep of Unihemispheric Concurrent Dual-Site anodal Transcranial Direct Current Stimulation combined with therapeutic exercise in Fibromyalgia patients.
Detailed description
Fibromyalgia (FM) is one of the rheumatic diseases with the greatest impact on the quality of life, whose etiology and pathophysiology is not yet fully demonstrated.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real UHCDS a-TDCS + Therapeutic Exercise | Experimental | Device: Real UHCDS a-tDCS, Device: Therapeutic exerciseReal unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise |
| Sham UHCDS a-TDCS + Therapeutic Exercise | Sham comparator | Device: Therapeutic exercise, Device: Sham UHCDS a-tDCSSham unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise |
| Therapeutic Exercise | Active comparator | Device: Therapeutic exerciseTherapeutic exercise. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18 and 65 years.
- Fulfilled the 2010 American Colleague of Rheumatology criteria for fibromyalgia.
- Able to participated in a therapeutic exercise program.
- Understanding of spoken and written Spanish.
Key exclusion criteria (10 listed)
- Pregnancy or breastfeeding.
- Metallic implants in the head.
- Tumor, trauma or surgery in the brain.
- Epilepsy or stroke.
- History of substance abuse in the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Real UHCDS a-tDCSReal 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. | Device | Real UHCDS a-TDCS + Therapeutic Exercise |
| Therapeutic exerciseThe 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. | Device | Real UHCDS a-TDCS + Therapeutic Exercise, Sham UHCDS a-TDCS + Therapeutic Exercise, Therapeutic Exercise |
| Sham UHCDS a-tDCSSham 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. | Device | Sham UHCDS a-TDCS + Therapeutic Exercise |
Primary outcome
Change in fatigue from baseline to post-treatment as assessed by MFI.
Time frame: Baseline; immediately after intervention; 1-month after intervention
The version adapted to Spanish from the Multidimensional Fatigue Inventory (MFI) will be used. The scale ranges from 0 to 100. Higher values represent a worse result.
Change in sleep quality from baseline to post-treatment as assessed by MOS-SS.
Time frame: Baseline; immediately after intervention; 1-month after intervention
The version adapted to Spanish from the Medical Outcomes Study Sleep Scale (MOS-SS) will be used. The scale ranges from 0 to 100. Higher values represent a worse result.
2 secondary outcomes
Fibromyalgia Impact Quality-of-Life
Time frame: Baseline; immediately after intervention; 1-month after intervention
Blinding
Time frame: Immediately after intervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Real UHCDS a-tDCS and Therapeutic exercise in people with Fibromyalgia, run by University of Castilla-La Mancha at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue from baseline to post-treatment as assessed by MFI. (time frame: Baseline; immediately after intervention; 1-month after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2024.