Neuromodulation of Lidocaine and Capsaicin Cream Effects on Pain Experience
Neuromodulation of Placebo and Nocebo Effects
1 other identifier
interventional
103
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable pain
Started May 2016
Longer than P75 for not_applicable pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 27, 2017
CompletedFirst Posted
Study publicly available on registry
April 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedResults Posted
Study results publicly available
July 7, 2020
CompletedJuly 7, 2020
June 1, 2020
2.8 years
January 27, 2017
May 13, 2020
June 19, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Comparison of Functional Connectivity Changes of the DLPFC Before and After tDCS Stimulation
We investigated the effects of cathodal (inhibition) and anodal (enhancement) tDCS on rDLPFC functional connectivity (FC) with the supplementary motor area (SMA) and anterior insula. Higher Fisher Z-scores represent greater resting-state functional connectivity.
up to 2 weeks
fMRI Resting States Functional Connectivity Changes During Pain Stimulation
We measured changes in blood oxygen level-dependent (BOLD) activity in the brain during pain stimulation. In the outcome measure data table, "placebo contrast" indicates lidocaine - neutral and "nocebo contrast" indicates capsaicin - neutral.
up to 2 weeks
Secondary Outcomes (1)
Gracely Sensory Scale Pain Rating Changes in Response to Lidocaine and Capsaicin Creams and tDCS
up to 2 weeks
Study Arms (3)
tDCS Enhancement
EXPERIMENTALIn this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.
tDCS Inhibition
EXPERIMENTALIn this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.
Sham tDCS
SHAM COMPARATORSham transcranial direct current stimulation (tDCS) does not provide real stimulation though you will not know this until your debriefing at the end of the study. Sham will be used to determine if the results of this study are due to the tDCS or other reasons.
Interventions
tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.
Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).
Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).
A neutral cream will be applied on the arm as a control.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
The sample size for this study was relatively small.
Results Point of Contact
- Title
- Jian Kong, Principal Investigator
- Organization
- Massachusetts General Hospital, Harvard Medical School
Study Officials
- PRINCIPAL INVESTIGATOR
Jian Kong
MGH
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
January 27, 2017
First Posted
April 6, 2017
Study Start
May 1, 2016
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
July 7, 2020
Results First Posted
July 7, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share