Effects of tDCS on People With Fibromyalgia

NCT05266989 | Completed

• 1 other identifier: 192/2021
• Study Type: observational
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Fibromyalgia

Keywords

Electroencephalography; EEG; Transcanial Stimulation; Strength

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  Once before and after each tDCS session

Secondary Outcomes (10)

• Socio-demographic information

  At week 1

• Physical activity level

  At week 1

• Impact of the disease

  At week 1

• Fear of falling

  At week 1

• Health-related quality of life

  At week 1

Study Arms (2)

Fibromyalgia

All participants will randomly participate through three tDCS conditions (1mA, 2mA and sham)

Other: Transcranial Direct Current Stimulation

Healthy Controls

All participants will randomly participate through three tDCS conditions (1mA, 2mA and sham)

Other: Transcranial Direct Current Stimulation

Interventions

Transcranial Direct Current Stimulation OTHER

Non-invasive technique that modulates the excitability of the cortex by applying low-intensity current

Fibromyalgia; Healthy Controls

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy and fibromyalgia women living in Caceres (Spain) and the surrounding area

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Extremadura: lead
• Ministerio de Asuntos Economicos y Transformación Digital, España: collaborator
• Junta de Extremadura, España: collaborator

Study Sites (1)

Facultad de Ciencias del Deporte

Cáceres, 10003, Spain

Location

MeSH Terms

Conditions

Fibromyalgia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Narcis Gusi

  Universidad de Extremadura

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: March 4, 2022
• Study Start: February 7, 2022
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

ES (1)