The Added Value of Transcranial Direct Current Stimulation (tDCS) During Exercise for People With Chronic Widespread Pain

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorVrije Universiteit Brussel

About this trial

Many people with chronic widespread pain (CWP) feel more pain and fatigue after exercise. This makes it hard to stay active. Unfortunately, the investigators do not fully understand why this happens and how to prevent it.

The primary goal of this study is to explore the underlying genetic and epigenetic mechanisms of BDNF gene in response to exercise, and investigate if transcranial direct current stimulation (tDCS) during exercise works to improve worsening symptoms response to exercise in people with CWP.

The investigators designed a randomized crossover study and will enroll 60 patients with CWP and 60 healthy controls. Participants will undergo 2 interventions in random order: 1) exercise + active tDCS, and 2) exercise + sham tDCS. Participants will visit the hospital twice with at least one week in between the visits.

Eligibility criteria

Qualifiers

Diagnosis of chronic widespread pain (CWP) or fibromyalgia;

Age between 18 and 70 years old;

Body mass index (BMI) ≤ 35;

Widespread Pain Index (WPI) assessment: the WPI questionnaire (0-19 points) will be used to record the number and distribution of painful body sites. Participants will be classified as having CWP if pain is reported on both sides of the body, above and below the waist, and in the axial skeleton, with pain symptoms lasting ≥ 3 months;

Disqualifiers

Current pregnancy or pregnancy within the past 12 months;

Contraindications for non-invasive brain stimulation (NIBS), in line with published safety guidelines;

History of neurological disorders, including epilepsy (personal or family history), traumatic brain injury, stroke, dementia, or Parkinson's disease;

Major medical conditions, including cancer, endocrine or metabolic disorders, urine, genital and cardiovascu-lar diseases (e.g., myocardial infarction, heart failure, arrhythmia, uncontrolled hypertension).

Trial design

Treatments tested in this trial

  • Active tDCS
  • Aerobic exercise
  • Sham tDCS

Treatment groups

120 Participants
are divided into 4 treatment groups

Locations

1
VUB1090, Jette Belgium

Sponsors and collaborators

Vrije Universiteit Brussel

Lead sponsor