Neuromodulation of Lidocaine and Capsaicin Cream Effects on Pain Experience

Pain Clinical Trial

Official title:

Neuromodulation of Placebo and Nocebo Effects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102710
• Other study ID #: 2015P000685
• Status: Completed
• Phase: N/A
• Start date: May 2016
• Est. completion date: March 2019

Study information

• Verified date: June 2020
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain

Intervention

Device:
• transcranial direct current stimulation (tDCS)
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.

Other:
• Lidocaine cream
Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).
• Capsaicin cream
Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).
• Control cream
A neutral cream will be applied on the arm as a control.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Charlestown	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Gracely Sensory Scale Pain Rating Changes in Response to Lidocaine and Capsaicin Creams and tDCS	The Gracely Sensory Scale allows participants to rate the intensity of heat pain stimuli on a scale from 0 to 20, with 0 indicating no pain sensation and 20 indicating extremely intense pain. The outcome measure data table shows mean pain ratings for the lidocaine, capsaicin, and neutral creams after enhancement, inhibition, or sham tDCS stimulation.	up to 2 weeks