The Warmth, Anticipation, Sensation, Aversion, and Body-part Imaging Study
Recruiting · NCT04653064 · Interventional (participants receive a specific treatment) · Lead sponsor: Trustees of Dartmouth College
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This functional magnetic-resonance imaging study of the brain will feature a within-subject crossover design to investigate the effects of a placebo cream on painful thermal stimulation rendered upon eight body sites. The investigators aim to 1.) improve the understanding of how the brain represents thermal pain responses somatotopically (i.e., across different body-sites) 2.) to test these brain representations with and without the presence of a pain-targeted placebo intervention, and 3.) to examine how these brain representations change prior to vs. during the delivery of thermal pain. They predict that placebo cream will downregulate the intensity of aversive brain activity representations, and to a lesser degree, sensation and somatotopic representations, both prior to and during painful thermal stimulation.
Who can take part
Inclusion criteria
- Subject must be a volunteer with a minimum age of 18 years and must be able and willing to provide written informed consent.
- If female, the subject must be non-lactating, not pregnant, and using a reliable contraception method.
- Subject must be able to read and speak English.
- Subject must be able to understand and follow the instructions of the investigator and understand all screening questionnaires.
- Subject must have no current or recent history of pathological pain.
- Subject must have abstained from alcohol and substance use for 48 hours.
- Subject must pass all fMRI screening tests.
Exclusion criteria
- If female, pregnancy.
- Inability to tolerate the scanning procedures (e.g., claustrophobia).
- Metal in body or prior history working with metal fragments (e.g., as a machinist).
- Inability to tolerate heat pain applied to the forearm.
- Reporting temporary abnormal levels of pain.
- Allergic response to the exfoliating cream.
- Current presence of pain.
- Current or past history of psychoactive substance abuse or dependence.
- Dementias.
- Movement disorders except familial tremor.
- CNS infection.
- CNS vasculitis.
- Inflammatory disease or autoimmune disease.
- CNS demyelinating disease (e.g. multiple sclerosis).
- Space occupying lesions (mass lesions, tumors).
- Congenital CNS abnormality (e.g. cerebral palsy).
- Seizure disorder.
- History of closed head trauma with loss of consciousness.
- History of cerebrovascular disease (stroke, TIAs).
- Abnormal MRI (except changes accounted for by technical factors or UBOs.
- Neuroendocrine disorders (e.g., Cushings disease).
- Uncorrected hypothyroidism or hyperthyroidism.
- Current or past history of cancer.
- Recent history (within two years) of myocardial infarction, severe cardiovascular disease, or currently active cardiovascular disease (e.g. angina, cardiomyopathy).
- Uncontrolled hypertension or hypotension.
- Chronic pain syndromes.
- Chronic fatigue syndromes.
- A history of neurologic disease or neuropathic pain.
- Prior treatment within the last month with any of the following: antidepressants, mood stabilizers, glucocorticoids, opiates.
- Prior treatment with any of the following: antipsychotics, isoniazid, centrally active antihypertensive drugs (e.g. clonidine, reserpine).
- Any other contraindications for MRI examination (e.g., metallic implants such as pacemakers, surgical aneurysm clips, or known metal fragments embedded in the body).
- Current treatment for psychiatric disorders including mood, anxiety, substance abuse, attention-deficit/hyperactivity disorder (ADHD), psychosis.
- Neurological disorders (e.g., taking dopamine agonists for Parkinson's) Cardiovascular disease or medication (e.g., taking ACE (angiotensin-converting-enzyme) inhibitors for cardiac remodeling).
- Frequent smoking (\> 5 cigarettes / day).
- Frequent alcohol use (\> 14 drinks / week).
- Frequent migraines (\> 5 / month on average).
Where it is running
1 location listed across 1 US state.
- Dartmouth College - Hanover, New Hampshire, United States