N/A
N=85
Neuromodulation of Lidocaine and Capsaicin Cream Effects on Pain Experience
Pain
Bottom Line
View on ClinicalTrials.gov: NCT03102710 ↗Enrolled (actual)
85
Serious AEs
0.0%
Results posted
Jul 2020
Primary outcome: Primary: Comparison of Functional Connectivity Changes of the DLPFC Before and After tDCS Stimulation — -0.11; -0.09; 0.08; -0.13 Fisher Z value
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- transcranial direct current stimulation (tDCS) (Device); Lidocaine cream (Other); Capsaicin cream (Other); Control cream (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Massachusetts General Hospital
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comparison of Functional Connectivity Changes of the DLPFC Before and After tDCS Stimulation |
-0.11; -0.09; 0.08; -0.13; -0.13; 0.07 | — |
| PRIMARY fMRI Resting States Functional Connectivity Changes During Pain Stimulation |
0.14; 0.50; -0.17; 0.26; 0.27; 0.25 | — |
| SECONDARY Gracely Sensory Scale Pain Rating Changes in Response to Lidocaine and Capsaicin Creams and tDCS |
8.54; 8.80; 9.01; 7.29; 6.41; 7.38 | 0.03 sig |
Summary
The aim of this study is to use a brain stimulation tool called transcranial direct current stimulation (tDCS) to investigate the analgesic (reducing sensitivity to pain) effects of lidocaine cream and the hyperalgesic (increasing sensitivity to pain) effects of capsaicin cream using a neutral cream as a control. tDCS stimulation has been shown to temporarily influence the way the stimulated part of the brain functions. With this method, the involvement of specific parts of the brain can be investigated in the working of the brain as a whole.
Eligibility Criteria
Inclusion Criteria
- Right handed healthy male and female adults aged 21-50
- No contraindications to fMRI scanning
- At least a 10th grade English-reading level; English can be a second language provided that the patients feel they understand all the questions used in the assessment measures.
Exclusion Criteria
- Current or past history of major medical, neurological, or psychiatric illness
- Claustrophobia
- History of head trauma
- Instability of responses to experimental pain
- Non-fluent speaker of English
- Presence of any contraindications to fMRI scanning. For example: cardiac pacemaker, metal implants, fear of closed spaces, pregnancy
- History of alcohol/substance abuse
Data sourced from ClinicalTrials.gov (NCT03102710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.