Mild brain stimulation added to exercise for chronic widespread pain

Unravelling the Epigenetic Mechanisms of Exercise-induced Pain in Chronic Widespread Pain: DNA Methylation Regulation of the Brain-derived Neurotrophic Factor Expression and Its Modulation by Transcranial Direct Current Stimulation

This study will test whether adding mild brain stimulation (tDCS) during a short bout of aerobic exercise helps people with chronic widespread pain have less pain and fatigue afterward.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Vrije Universiteit Brussel (other)
• Locations: 1 site (Jette)
• Trial ID: NCT07212829 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–70 with chronic widespread pain or fibromyalgia, BMI ≤ 35, widespread pain for ≥3 months, and stable medications for at least one month are ideal candidates.

Not a fit: People who cannot safely perform submaximal aerobic exercise, have contraindications to brain stimulation, or who do not meet the study's inclusion criteria are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this approach could reduce exercise-induced pain flares and help people with chronic widespread pain stay more physically active.

How similar studies have performed: Previous tDCS studies in chronic pain have shown mixed but sometimes promising symptom reductions, while combining tDCS with exercise and tracking BDNF methylation is a relatively novel approach.

Eligibility criteria

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 this trial is running

Jette

• VUB — Jette, Belgium (RECRUITING)

Study contacts

• Study coordinator: Pain in Motion research group

Conditions: Chronic Widespread Pain, Fibromyalgia, BDNF, pain, exercise, DNA methylation