NCT05726149

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 26, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 13, 2023

Completed
16 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

9 months

First QC Date

January 26, 2023

Last Update Submit

May 24, 2024

Conditions

Fibromyalgia

Keywords

NeuromodulationTherapeutic exerciseFatigueSleep

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline; immediately after intervention; 1-month after intervention

Secondary Outcomes (2)

  • Fibromyalgia Impact Quality-of-Life

    Baseline; immediately after intervention; 1-month after intervention

  • Blinding

    Immediately after intervention.

Study Arms (3)

Real UHCDS a-TDCS + Therapeutic Exercise

EXPERIMENTAL

Real unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise

Device: Real UHCDS a-tDCSDevice: Therapeutic exercise

Sham UHCDS a-TDCS + Therapeutic Exercise

SHAM COMPARATOR

Sham unihemispheric concurrent dual-site anodal transcranial direct current stimulation combined with therapeutic exercise

Device: Therapeutic exerciseDevice: Sham UHCDS a-tDCS

Therapeutic Exercise

ACTIVE COMPARATOR

Therapeutic exercise.

Device: Therapeutic exercise

Interventions

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.

Real UHCDS a-TDCS + Therapeutic Exercise
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.

Real UHCDS a-TDCS + Therapeutic ExerciseSham UHCDS a-TDCS + Therapeutic ExerciseTherapeutic Exercise
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.

Sham UHCDS a-TDCS + Therapeutic Exercise

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Diagnosed psychiatric pathology.
  • Rheumatic pathology not medically controlled.
  • Coexisting autoimmune pathology.
  • Chronic inflammatory disease (rheumatoid arthritis, erythematosus systemic lupus, inflammatory bowel disease).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain

Location

MeSH Terms

Conditions

FibromyalgiaFatigue

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Muscular DiseasesMusculoskeletal DiseasesRheumatic DiseasesNeuromuscular DiseasesNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2023

First Posted

February 13, 2023

Study Start

March 1, 2023

Primary Completion

November 15, 2023

Study Completion

November 30, 2023

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations

ES(1)