Mild brain stimulation added to exercise for chronic widespread pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In a randomized crossover design, 60 people with chronic widespread pain and 60 healthy controls each complete two hospital sessions at least one week apart: 20 minutes of submaximal aerobic exercise paired with either active transcranial direct current stimulation (tDCS, 30 minutes) or sham tDCS. The order of active and sham sessions is randomized and balanced for each participant. Pain intensity, serum BDNF protein, and BDNF gene methylation will be measured before and after each session to link symptom changes with molecular responses. The study aims to determine whether tDCS alters post-exercise symptom flares and associated BDNF-related genetic or epigenetic markers.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Patients

Participants in the patient group must meet all of the following criteria:

1. Diagnosis of chronic widespread pain (CWP) or fibromyalgia;
2. Age between 18 and 70 years old;
3. Body mass index (BMI) ≤ 35;
4. 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;
5. Stable medication use for at least 1 month prior to study entry.

Healthy control group

Participants in the healthy control group must meet all of the following criteria:

1. Age between 18 and 70 years old;
2. Body mass index (BMI) ≤ 35;
3. No chronic conditions, such as chronic pain and diabetes.

Exclusion Criteria:

For both patients and healthy controls, participants will be excluded if they meet any of the following:

1. Current pregnancy or pregnancy within the past 12 months;
2. Contraindications for non-invasive brain stimulation (NIBS), in line with published safety guidelines;
3. History of neurological disorders, including epilepsy (personal or family history), traumatic brain injury, stroke, dementia, or Parkinson's disease;
4. Major medical conditions, including cancer, endocrine or metabolic disorders, urine, genital and cardiovascu-lar diseases (e.g., myocardial infarction, heart failure, arrhythmia, uncontrolled hypertension).
5. Substance abuse.
6. Presence of psychiatric disorders other than depression or anxiety.

Where it's running

• Vub
  Jette, Belgium Recruiting

Study contacts

• Study coordinator: Pain in Motion research group
• Email: huanyu.xiong@vub.be
• Phone: +32 497783956

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.