Clinical trial NCT05266989: Effects of tDCS on People With Fibromyalgia
Official title: Effects of Transcranial Direct Current Stimulation on Brain Electrical Activity, Heart Rate Variability, and Dual-Task Performance in Healthy and Fibromyalgia Women
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Fibromyalgia
Keywords: Electroencephalography
EEG
Transcanial Stimulation
Strength
Lead sponsor: University of Extremadura
Sponsor class: OTHER
Collaborators: name: Ministerio de Asuntos Economicos y Transformación Digital, España
name: Junta de Extremadura, España
First posted: 2022-03-04
Enrollment: 26
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy and fibromyalgia women living in Caceres (Spain) and the surrounding area

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Be able to communicate with the research staff
* Have read, understood, and signed the informed consent form

Exclusion Criteria:

* 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

Primary outcomes:
measure: Degree of change in electroencephalography (EEG) between pre and post tDCS session
timeFrame: Once before and after each tDCS session
measure: Degree of change in heart rate variability (HRV) between pre and post tDCS session
timeFrame: Once before and after each tDCS session
measure: Degree of change in balance between pre and post tDCS session
timeFrame: Once before and after each tDCS session
measure: Degree of change in strength between pre and post tDCS session
timeFrame: Once before and after each tDCS session
measure: Degree of change in balance, under dual-task condition, between pre and post tDCS session
timeFrame: Once before and after each tDCS session
measure: Degree of change in strenght, under dual-task condition, between pre and post tDCS session
timeFrame: Once before and after each tDCS session
Secondary outcomes:
measure: Socio-demographic information
timeFrame: At week 1
measure: Physical activity level
timeFrame: At week 1
measure: Impact of the disease
timeFrame: At week 1
measure: Fear of falling
timeFrame: At week 1
measure: Health-related quality of life
timeFrame: At week 1
measure: Sleep Quality
timeFrame: At week 1
measure: Cognitive Impairment
timeFrame: At week 1
measure: Degree of change in sensations related to tDCS
timeFrame: Once after the tDCS sessions
measure: Bioelectrical impedance analysis
timeFrame: At week 1
measure: Height (meters)
timeFrame: At week 1
Other outcomes:
Locations:
city: Caceres
country: Spain
facility: Facultad de Ciencias del Deporte
Study officials:
affiliation: Universidad de Extremadura
name: Narcis Gusi
role: STUDY_DIRECTOR
References: