The Added Value of Transcranial Direct Current Stimulation (tDCS) During Exercise for People With 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
Vrije Universiteit Brussel
120 participants
Feb 1, 2026
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria12
- Patients
- Participants in the patient group must meet all of the following criteria:
- 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;
- 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:
- Age between 18 and 70 years old;
- Body mass index (BMI) ≤ 35;
- No chronic conditions, such as chronic pain and diabetes.
Exclusion Criteria7
- For both patients and healthy controls, participants will be excluded if they meet any of the following:
- 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).
- Substance abuse.
- Presence of psychiatric disorders other than depression or anxiety.
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Interventions
tDCS is performed using a monophasic current device. Pairs of silicon sponge sur-face electrodes (35 cm2) are soaked in saline and positioned as follows: the anode is placed over the region of the dorsolateral prefrontal cortex (DLPFC) per the international 10/20 system at point F3 (left DLPFC), and the cathode is placed on the contralateral supraorbital area (FP2 site). For active tDCS, the current is ramped up for 30 seconds until the center electrode reaches a target intensity of 2 mA, then remains for 29 minutes before dropping for another 30s.
Participants will perform a moderate aerobic exercise (AE, known as aerobic power index), using a cycle er-gometer. The exercise intensity is moderate and individually tailored based on each participant's estimated maximum heart rate (HRmax), calculated using the validated formula: HRmax = 211 - (0.64 × age).
tDCS is performed using a monophasic current device. Pairs of silicon sponge sur-face electrodes (35 cm2) are soaked in saline and positioned as follows: the anode is placed over the region of the dorsolateral prefrontal cortex (DLPFC) per the international 10/20 system at point F3 (left DLPFC), and the cathode is placed on the contralateral supraorbital area (FP2 site). In the sham condition, current is ramped up to 2.0 mA for 30 seconds and then ramped down to 0 mA, with the total session duration matched to the active condition. This procedure was used to mimic the tingling sensa-tions typically experienced at the beginning of stimulation. Participants received identical instructions, session timing, and room setup across conditions.
Locations(1)
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NCT07212829