None listed
Conditions
Brief summary
This study explores whether a non-invasive brain stimulation technique called transcranial Alternating Current Stimulation (tACS) can effectively reduce chronic gut symptoms in patients with gut disorders. Researchers hypothesise that applying this gentle electrical stimulation to specific parts of the cortex will decrease symptom severity, particularly nausea, more effectively than a sham treatment. Up to 60 participants will receive both active and sham stimulation in a randomised order during a single session while their symptoms are tracked in real-time via a mobile application. Alongside brain stimulation, the study uses high-tech "mapping" on the abdomen to monitor the stomach’s electrical rhythms, as well as other physiological biomarkers like heart rate. The ultimate goal is to validate a safe, drug-free therapy that targets the brain's symptom-processing centres to provide relief for those with debilitating symptoms.
Interventions
The active treatment (intervention) is a non-invasive transcranial brain stimulation protocol targeting cortical regions implicated in nausea processing. This intervention aims to evaluate the efficacy of this non-invasive form of stimulation in reducing the severity of nausea and other upper gastrointestinal symptoms in patients with gut disorders.
The stimulation will be delivered via a standard battery-powered isolated constant-current stimulator coupled with a digital stimulator. Delivery
The active treatment (intervention) is a non-invasive transcranial brain stimulation protocol targeting cortical regions implicated in nausea processing. This intervention aims to evaluate the efficacy of this non-invasive form of stimulation in reducing the severity of nausea and other upper gastrointestinal symptoms in patients with gut disorders. The stimulation will be delivered via a standard battery-powered isolated constant-current stimulator coupled with a digital stimulator. Delivery is achieved via standard hydrogel surface electrodes, or equivalent. Following an overnight fast and baseline recordings, the stimulation procedure will last 2-4 hours. During the session patients will consume a standardised nutrient liquid and energy bar meal, and will rest in a recumbent position, whilst logging their upper gastrointestinal symptoms using a validated digital app. Intervention providers will be members of the research team with experience in upper gastrointestinal and neural electrophysiology. The intervention is delivered face-to-face and individually to each participant during a single supervised clinical visit at an outpatient clinical research facility setting. This is a sham-controlled, within-session crossover study. Participants undergo multiple stimulation cycles of both the active treatment and the sham control lasting 21 minutes separated by washout periods of 9 minutes. The intervention is not personalised or tailored; all participants receive the same standardised stimulation parameters (0.08-0.2 Hz, +/- 2mA). At this stage, the entire process will repeat for a total of 2 hours postprandially (2 cycles: each participant receives the active treatment twice and the sham control twice). Intervention fidelity will be maintained by standardising the anatomical placement of the electrodes using the International 10-20 system guidelines. Symptom data collection will be standardised via automated prompts through a validated digital application. This will be accompanied with simultaneous non-invasive body surface electrophysiological recordings of gastric electrical activity and peripheral physiological monitoring (heart rate, heart rate variability, respiratory rate, skin conductance, peripheral temperature, peripheral oxygen saturation, and blood pressure).
Sponsors
The University of Auckland
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18–75 years. 2. Patients with upper GI symptoms: diagnosis of gut disorders, e.g. gastroparesis, Chronic Nausea and Vomiting Syndrome (CNVS), functional dyspepsia. 3. Ability to provide informed consent for transcranial Alternating Current Stimulation (tACS), Body Surface Gastric Mapping (BSGM), and physiological biomarker measurements.
Exclusion criteria
1. Contraindications to tACS: history of epilepsy or seizures, metallic implants in the head/neck (excluding dental), pacemakers, implanted defibrillators, or history of skull issues. 2. Compromised skin integrity: open wounds, eczema, fragile skin at key electrode sites (forehead, scalp, epigastrium), or history of major sensitivity to adhesives, cosmetics or lotions. 3. Pregnancy, as confirmed by history or test. 4. Those unable to provide informed consent, i.e. non-English speakers, those with severe cognitive impairment, vulnerable groups.
Outcome results
None listed