FibromyalgiaNCT05266989
Effects of tDCS on People With Fibromyalgia
An observational study of Fibromyalgia, run by University of Extremadura at 1 site in Spain.
Trial summary
People with fibromyalgia could experience physical and cognitive impairment as well as higher dual-task cost than healthy people when two tasks are performed simultaneously. Transcranial direct current stimulation is a promising non-pharmacological therapy. Read more about this study
- Who is it for?
- Ages 30 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Transcranial Direct Current Stimulation
- How many people
- 26 participants
- Where
- 1 siteSpain
- Study dates
- 7 Feb 2022to 14 Mar 2022
- Phase
- Observational
- 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 30 to 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy and fibromyalgia women living in Caceres (Spain) and the surrounding area
Who may be able to join
- Be able to communicate with the research staff
- Have read, understood, and signed the informed consent form
Who cannot join
- Physiatric or neurological disorders
- Pharmacological treatment for anxiety or depression
- Substance abuse or dependence
- Contraindication for physical effort
- Difficulty in maintaining balance
- Leg injury that interferes with flexion and extension of the knee
- Being pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcranial Direct Current Stimulation on Brain Electrical Activity, Heart Rate Variability, and Dual-Task Performance in Healthy and Fibromyalgia Women
People with fibromyalgia could experience physical and cognitive impairment as well as higher dual-task cost than healthy people when two tasks are performed simultaneously. Transcranial direct current stimulation is a promising non-pharmacological therapy. However, there is insufficient evidence about the intensities dose-response. Therefore, this protocol aims to 1) to compare the effectiveness and the impact of two tDCS intensities (1mA and 2mA) on cognitive, motor, brain functions, and cardiac autonomic modulation; 2) to study the impact of tDCS on the dual-task performance and creativity after applying tDCS in the dorsolateral prefrontal cortex. As hypotheses, a reduction of cognitive-motor interference in dual-task performance and also a modification in neurophysiological parameters, and an improvement in cardiac autonomic modulation are expected. Finally, no different effects are obtained depending on the intensity applied.
Read the detailed description
Fibromyalgia is characterized by widespread pain and other associated symptoms, including stiffness, fatigue, non-recovery sleep, anxiety, or depression. On a physical level, people with FM frequently suffer from a sedentary state which reduces cardiovascular fitness and leads to mobility, strength and balance impairments. On a cognitive level, people with FM have often impaired cognitive functions such as memory, attention, processing speed, and executive functions. As a result of all of these symptoms, people with FM have a decreased performance in activities of daily living that are commonly presented as a simultaneous execution of two or more task at the same time (dual-task; DT).
To the knowledge of the investigators, no studies have focused on the application of transcranial direct current stimulation (tDCS) on the dorsolateral prefrontal cortex (DLPFC) to reduce the interference in DT performance. Furthermore, there are no studies that have studied the effects of different intensities of tDCS on DLPFC in people with FM in DT performance. Similarly, there are no studies that have focused on describing how neurophysiological variables may be modified in people with FM during DT performance. Therefore, it seems interesting to know how tDCS can influence these types of variables in order to improve the quality of life of this population and to open new frontiers for research.
The hypotheses that are proposed for this study are as follows: a) the application of tDCS will improve physical performance in physical variables that will be measured through balance and strength tasks; b) the application of tDCS will improve performance on neurophysiological variables that will be measured through brain electrical activity and HRV; c) the application of tDCS will improve performance in DT conditions as well as in creativity tasks; d) tDCS will have different effects depending on the variability of fibromyalgia symptoms presented (pain, sleep problems and depression); e) no significant effects on the variables would be expected depending on the type of tDCS intensity applied.
At this point, the main objectives of this protocol are: 1) to compare the effectiveness and the impact of two tDCS intensities (1mA and 2mA) on neurophysiological variables, cognitive, and motor functions; 2) to study the impact of tDCS on the dual-task performance and creativity after applying tDCS in dorsolateral prefrontal cortex.
- Conditions
- Fibromyalgia
- Being tested
- Transcranial Direct Current Stimulation
- Keywords
- Electroencephalography, EEG, Transcanial Stimulation, Strength
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Direct Current StimulationOther
Non-invasive technique that modulates the excitability of the cortex by applying low-intensity current
| Study group | Role | What they receive |
|---|---|---|
| Fibromyalgia | All participants will randomly participate through three tDCS conditions (1mA, 2mA and sham) Receives: Other: Transcranial Direct Current Stimulation | |
| Healthy Controls | All participants will randomly participate through three tDCS conditions (1mA, 2mA and sham) Receives: Other: Transcranial Direct Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of change in electroencephalography (EEG) between pre and post tDCS session
The Enobio instrument (Neuroelectrics) and Neuroelectrics instrument driver software (NIC1) will be used to record EEG. Theta, alpha and beta power spectrums will be extracted from a 5 minute recording.
Measured: Once before and after each tDCS session
Degree of change in heart rate variability (HRV) between pre and post tDCS session
The Enobio instrument (Neuroelectrics) and Neuroelectrics instrument driver software (NIC1) will be used to record HRV. Time domain (SDNN, RMSSD, RR-interval and pNN50), frequency domain (LFnu, HFnu, LF/HF and total power) and non-linear measures (SampEn, SD1 and SD2) will be extracted from a 5 minute recording.
Measured: Once before and after each tDCS session
Degree of change in balance between pre and post tDCS session
The tests will be static position with eyes open and static position with eyes closed. The test will be performed on a Kistler force platform.
Measured: Once before and after each tDCS session
Degree of change in strength between pre and post tDCS session
The execution of the test consists of performing a concentric contraction of knee flexion and extension six times consecutively and without pause between repetitions at a speed of 60 /s and in a range of movement from 0 to 90 degrees, being 0 full extension and 90 flexion. The test will be performed on the isokinetic dynamometer Multi-Joint 3, Biodex Medical Sistems.
Measured: Once before and after each tDCS session
Degree of change in balance, under dual-task condition, between pre and post tDCS session
Participants will simultaneously perform the balance test (static position with eyes open and static position with eyes closed) and a cognitive task. The cognitive task will consist of two-by-two substractions from a number greater than 100.
Measured: Once before and after each tDCS session
Degree of change in strenght, under dual-task condition, between pre and post tDCS session
Participants will simultaneously perform the strenght test (conducting a concentric contraction of knee flexion and extension six times consecutively and without pause between repetitions at a speed of 60 /s and in a range of movement from 0 to 90 degrees, being 0 full extension and 90 flexion) and a cognitive task. The cognitive task will consist of two-by-two substractions from a number greater than 100.
Measured: Once before and after each tDCS session
Secondary outcomes (10)
Socio-demographic information
Age, level of education, injuries, or falls in the last few months, as well as other health related information, will be asked.
Measured: At week 1
Physical activity level
International Physical activity Questionnaire (IPAQ): results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. Scoring a low level of physical activity on the IPAQ means that you are not meeting any of the criteria for either moderate or high levels of physical activity.
Measured: At week 1
Impact of the disease
Fibromialgia Impact Questionnaire Revised (FIQ-R): the minimum score is 0 and the maximum is 100, corresponding to the worst overall symptom impact.
Measured: At week 1
Fear of falling
Falls Efficacy Scale International (FES-I): the minimum score is 16 and the maximum is 64. The higher the score, the greater the fear of falling.
Measured: At week 1
Health-related quality of life
EuroQol- 5 dimensions- 5 levels (EQ-5D-5L) (range 0 to 100 with higher values corresponding to better health status).
Measured: At week 1
Sleep Quality
Pittsburg Sleep Quality Index (PSQI) (range 0 to 21, with higher score referring to worse sleep quality).
Measured: At week 1
Cognitive Impairment
Montreal Cognitive Assessment (MoCA) (range 0 to 35 with higher values corresponding to better cognitive function).
Measured: At week 1
Degree of change in sensations related to tDCS
Survey of sensations related to tDCS
Measured: Once after the tDCS sessions
Bioelectrical impedance analysis
Body composition will be measured with the Tanita BC-418 Body Composition Analyzer
Measured: At week 1
Height (meters)
Using a SECA 285 model.
Measured: At week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2022
- Study start7 Feb 2022
- Primary completion14 Mar 2022
- Study completion14 Mar 2022
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Extremadura
- Sponsor type
- University, hospital or other
- Collaborators
- Ministerio de Asuntos Economicos y Transformación Digital, España, Junta de Extremadura, España
- Responsible party
- Principal investigator, Narcis Gusi, University of Extremadura
- Investigators
- Narcis Gusi, Study director, Universidad de Extremadura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05266989
- Sponsor's protocol ID
- 192/2021
- Status last verified
- Nov 2022
- First submitted
- 1 Feb 2022
- Last updated
- 14 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing will be evaluated upon reasonable request by the research group.
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation on Brain Electrical Activity, Heart Rate Variability, and Dual-Task Performance in Healthy and Fibromyalgia Women
- ClinicalTrials.gov ID
- NCT05266989
- Acronym / sponsor ID
- 192/2021
- Conditions
- Fibromyalgia
- Keywords
- Electroencephalography, EEG, Transcanial Stimulation, Strength
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University of ExtremaduraUniversity, hospital or other
- Collaborators
- Ministerio de Asuntos Economicos y Transformación Digital, España, Junta de Extremadura, España
- Study start
- 7 Feb 2022 (actual)
- Primary completion
- 14 Mar 2022 (actual)
- Study completion
- 14 Mar 2022 (actual)
- First posted
- 4 Mar 2022 (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.
People with fibromyalgia could experience physical and cognitive impairment as well as higher dual-task cost than healthy people when two tasks are performed simultaneously. Transcranial direct current stimulation is a promising non-pharmacological therapy. However, there is insufficient evidence about the intensities dose-response. Therefore, this protocol aims to 1) to compare the effectiveness and the impact of two tDCS intensities (1mA and 2mA) on cognitive, motor, brain functions, and cardiac autonomic modulation; 2) to study the impact of tDCS on the dual-task performance and creativity after applying tDCS in the dorsolateral prefrontal cortex. As hypotheses, a reduction of cognitive-motor interference in dual-task performance and also a modification in neurophysiological parameters, and an improvement in cardiac autonomic modulation are expected. Finally, no different effects are obtained depending on the intensity applied.
Detailed description
Fibromyalgia is characterized by widespread pain and other associated symptoms, including stiffness, fatigue, non-recovery sleep, anxiety, or depression. On a physical level, people with FM frequently suffer from a sedentary state which reduces cardiovascular fitness and leads to mobility, strength and balance impairments. On a cognitive level, people with FM have often impaired cognitive functions such as memory, attention, processing speed, and executive functions. As a result of all of these symptoms, people with FM have a decreased performance in activities of daily living that are commonly presented as a simultaneous execution of two or more task at the same time (dual-task; DT).
To the knowledge of the investigators, no studies have focused on the application of transcranial direct current stimulation (tDCS) on the dorsolateral prefrontal cortex (DLPFC) to reduce the interference in DT performance. Furthermore, there are no studies that have studied the effects of different intensities of tDCS on DLPFC in people with FM in DT performance. Similarly, there are no studies that have focused on describing how neurophysiological variables may be modified in people with FM during DT performance. Therefore, it seems interesting to know how tDCS can influence these types of variables in order to improve the quality of life of this population and to open new frontiers for research.
The hypotheses that are proposed for this study are as follows: a) the application of tDCS will improve physical performance in physical variables that will be measured through balance and strength tasks; b) the application of tDCS will improve performance on neurophysiological variables that will be measured through brain electrical activity and HRV; c) the application of tDCS will improve performance in DT conditions as well as in creativity tasks; d) tDCS will have different effects depending on the variability of fibromyalgia symptoms presented (pain, sleep problems and depression); e) no significant effects on the variables would be expected depending on the type of tDCS intensity applied.
At this point, the main objectives of this protocol are: 1) to compare the effectiveness and the impact of two tDCS intensities (1mA and 2mA) on neurophysiological variables, cognitive, and motor functions; 2) to study the impact of tDCS on the dual-task performance and creativity after applying tDCS in dorsolateral prefrontal cortex.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fibromyalgia | – | Other: Transcranial Direct Current StimulationAll participants will randomly participate through three tDCS conditions (1mA, 2mA and sham) |
| Healthy Controls | – | Other: Transcranial Direct Current StimulationAll participants will randomly participate through three tDCS conditions (1mA, 2mA and sham) |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy and fibromyalgia women living in Caceres (Spain) and the surrounding area
Key inclusion criteria (2 listed)
- Be able to communicate with the research staff
- Have read, understood, and signed the informed consent form
Key exclusion criteria (7 listed)
- Physiatric or neurological disorders
- Pharmacological treatment for anxiety or depression
- Substance abuse or dependence
- Contraindication for physical effort
- Difficulty in maintaining balance
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 |
|---|---|---|
| Transcranial Direct Current StimulationNon-invasive technique that modulates the excitability of the cortex by applying low-intensity current | Other | Fibromyalgia, Healthy Controls |
Primary outcome
Degree of change in electroencephalography (EEG) between pre and post tDCS session
Time frame: Once before and after each tDCS session
The Enobio instrument (Neuroelectrics) and Neuroelectrics instrument driver software (NIC1) will be used to record EEG. Theta, alpha and beta power spectrums will be extracted from a 5 minute recording.
Degree of change in heart rate variability (HRV) between pre and post tDCS session
Time frame: Once before and after each tDCS session
The Enobio instrument (Neuroelectrics) and Neuroelectrics instrument driver software (NIC1) will be used to record HRV. Time domain (SDNN, RMSSD, RR-interval and pNN50), frequency domain (LFnu, HFnu, LF/HF and total power) and non-linear measures (SampEn, SD1 and SD2) will be extracted from a 5 minute recording.
Degree of change in balance between pre and post tDCS session
Time frame: Once before and after each tDCS session
The tests will be static position with eyes open and static position with eyes closed. The test will be performed on a Kistler force platform.
Degree of change in strength between pre and post tDCS session
Time frame: Once before and after each tDCS session
The execution of the test consists of performing a concentric contraction of knee flexion and extension six times consecutively and without pause between repetitions at a speed of 60 /s and in a range of movement from 0 to 90 degrees, being 0 full extension and 90 flexion. The test will be performed on the isokinetic dynamometer Multi-Joint 3, Biodex Medical Sistems.
Degree of change in balance, under dual-task condition, between pre and post tDCS session
Time frame: Once before and after each tDCS session
Participants will simultaneously perform the balance test (static position with eyes open and static position with eyes closed) and a cognitive task. The cognitive task will consist of two-by-two substractions from a number greater than 100.
Degree of change in strenght, under dual-task condition, between pre and post tDCS session
Time frame: Once before and after each tDCS session
Participants will simultaneously perform the strenght test (conducting a concentric contraction of knee flexion and extension six times consecutively and without pause between repetitions at a speed of 60 /s and in a range of movement from 0 to 90 degrees, being 0 full extension and 90 flexion) and a cognitive task. The cognitive task will consist of two-by-two substractions from a number greater than 100.
10 secondary outcomes
Socio-demographic information
Time frame: At week 1
Physical activity level
Time frame: At week 1
Impact of the disease
Time frame: At week 1
Fear of falling
Time frame: At week 1
Health-related quality of life
Time frame: At week 1
Sleep Quality
Time frame: At week 1
Cognitive Impairment
Time frame: At week 1
Degree of change in sensations related to tDCS
Time frame: Once after the tDCS sessions
Bioelectrical impedance analysis
Time frame: At week 1
Height (meters)
Time frame: At week 1
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 14 Nov 2022.
- Individual participant dataSharing planned: Undecided. Data sharing will be evaluated upon reasonable request by the research group.
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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.
Narcis Gusi study director
Universidad de Extremadura
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fibromyalgia, run by University of Extremadura 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 2 inclusion and 7 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 14 Nov 2022. 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. 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?
Degree of change in electroencephalography (EEG) between pre and post tDCS session (time frame: Once before and after each tDCS session). The study lists 6 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 14 Nov 2022.