Trial Outcomes & Findings for Neuromodulation of Lidocaine and Capsaicin Cream Effects on Pain Experience (NCT NCT03102710)
NCT ID: NCT03102710
Last Updated: 2020-07-07
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
103 participants
Primary outcome timeframe
up to 2 weeks
Results posted on
2020-07-07
Participant Flow
18 subjects were dropped prior to randomization. Reasons for this included inconsistent or non-differentiable pain ratings to heat stimuli, pain thresholds that were too high or low, inability to finish subsequent sessions, too much discomfort with noxious stimuli, no SSN/hairstyle incompatible with tDCS, participated in a previous pain study.
Participant milestones
| Measure |
tDCS Enhancement
In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.
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.
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.
|
tDCS Inhibition
In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.
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.
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.
|
Sham tDCS
Sham 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 results of this study are due to tDCS or other reasons.
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.
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).
|
|---|---|---|---|
|
Overall Study
STARTED
|
28
|
30
|
27
|
|
Overall Study
COMPLETED
|
27
|
27
|
27
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
0
|
Reasons for withdrawal
| Measure |
tDCS Enhancement
In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.
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.
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.
|
tDCS Inhibition
In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.
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.
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.
|
Sham tDCS
Sham 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 results of this study are due to tDCS or other reasons.
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.
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).
|
|---|---|---|---|
|
Overall Study
Dental metal affected MRI scan quality
|
1
|
0
|
0
|
|
Overall Study
Technical issues during final MRI scan
|
0
|
1
|
0
|
|
Overall Study
Nausea during MRI scan
|
0
|
1
|
0
|
|
Overall Study
Subject unable to attend final session
|
0
|
1
|
0
|
Baseline Characteristics
Neuromodulation of Lidocaine and Capsaicin Cream Effects on Pain Experience
Baseline characteristics by cohort
| Measure |
tDCS Enhancement
n=27 Participants
In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.
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.
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.
|
tDCS Inhibition
n=27 Participants
In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.
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.
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.
|
Sham tDCS
n=27 Participants
Sham 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 results of this study are due to tDCS or other reasons.
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.
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).
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
27.42 years
n=5 Participants
|
26.87 years
n=7 Participants
|
27.89 years
n=5 Participants
|
27.39 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
37 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
20 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
52 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
27 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
81 Participants
n=4 Participants
|
|
Baseline pain ratings for low pain stimuli
|
6.05 units on a scale
STANDARD_DEVIATION 2.67 • n=5 Participants
|
4.54 units on a scale
STANDARD_DEVIATION 2.04 • n=7 Participants
|
5.08 units on a scale
STANDARD_DEVIATION 2.14 • n=5 Participants
|
5.22 units on a scale
STANDARD_DEVIATION 2.36 • n=4 Participants
|
|
Baseline pain ratings for moderate pain stimuli
|
9.31 units on a scale
STANDARD_DEVIATION 1.97 • n=5 Participants
|
8.84 units on a scale
STANDARD_DEVIATION 2.54 • n=7 Participants
|
8.97 units on a scale
STANDARD_DEVIATION 2.34 • n=5 Participants
|
9.04 units on a scale
STANDARD_DEVIATION 2.28 • n=4 Participants
|
|
Baseline pain ratings for high pain stimuli
|
14.52 units on a scale
STANDARD_DEVIATION 2.67 • n=5 Participants
|
14.56 units on a scale
STANDARD_DEVIATION 2.33 • n=7 Participants
|
14.52 units on a scale
STANDARD_DEVIATION 2.20 • n=5 Participants
|
14.53 units on a scale
STANDARD_DEVIATION 2.38 • n=4 Participants
|
PRIMARY outcome
Timeframe: up to 2 weeksPopulation: Participants who completed all study sessions
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.
Outcome measures
| Measure |
tDCS Enhancement
n=27 Participants
In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.
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.
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.
|
tDCS Inhibition
n=27 Participants
In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.
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.
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.
|
Sham tDCS
n=27 Participants
Sham 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 results of this study are due to tDCS or other reasons.
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.
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).
|
|---|---|---|---|
|
Comparison of Functional Connectivity Changes of the DLPFC Before and After tDCS Stimulation
rDLPFC-SMA Functional Connectivity (post-pre)
|
-0.11 Fisher Z value
Standard Deviation 0.22
|
-0.09 Fisher Z value
Standard Deviation 0.16
|
0.08 Fisher Z value
Standard Deviation 0.20
|
|
Comparison of Functional Connectivity Changes of the DLPFC Before and After tDCS Stimulation
rDLPFC-Insula Functional Connectivity (post-pre)
|
-0.13 Fisher Z value
Standard Deviation 0.23
|
-0.13 Fisher Z value
Standard Deviation 0.20
|
0.07 Fisher Z value
Standard Deviation 0.18
|
PRIMARY outcome
Timeframe: up to 2 weeksPopulation: Participants who completed all study sessions and whose task fMRI data had no issues.
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.
Outcome measures
| Measure |
tDCS Enhancement
n=26 Participants
In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.
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.
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.
|
tDCS Inhibition
n=27 Participants
In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.
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.
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.
|
Sham tDCS
n=26 Participants
Sham 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 results of this study are due to tDCS or other reasons.
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.
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).
|
|---|---|---|---|
|
fMRI Resting States Functional Connectivity Changes During Pain Stimulation
BOLD activity change in mPFC/ACC: nocebo contrast
|
0.26 Arbitrary unit
Standard Deviation 0.80
|
0.27 Arbitrary unit
Standard Deviation 0.81
|
0.25 Arbitrary unit
Standard Deviation 1.15
|
|
fMRI Resting States Functional Connectivity Changes During Pain Stimulation
BOLD activity in the left insula: placebo contrast
|
0.11 Arbitrary unit
Standard Deviation 0.35
|
0.21 Arbitrary unit
Standard Deviation 0.81
|
0.18 Arbitrary unit
Standard Deviation 0.64
|
|
fMRI Resting States Functional Connectivity Changes During Pain Stimulation
BOLD activity in the left insula: nocebo contrast
|
0.08 Arbitrary unit
Standard Deviation 0.36
|
0.16 Arbitrary unit
Standard Deviation 0.35
|
0.30 Arbitrary unit
Standard Deviation 0.39
|
|
fMRI Resting States Functional Connectivity Changes During Pain Stimulation
BOLD activity change in mPFC/ACC: placebo contrast
|
0.14 Arbitrary unit
Standard Deviation 0.47
|
0.50 Arbitrary unit
Standard Deviation 0.57
|
-0.17 Arbitrary unit
Standard Deviation 0.68
|
SECONDARY outcome
Timeframe: up to 2 weeksPopulation: Participants who completed all study sessions
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.
Outcome measures
| Measure |
tDCS Enhancement
n=27 Participants
In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.
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.
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.
|
tDCS Inhibition
n=27 Participants
In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.
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.
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.
|
Sham tDCS
n=27 Participants
Sham 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 results of this study are due to tDCS or other reasons.
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.
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).
|
|---|---|---|---|
|
Gracely Sensory Scale Pain Rating Changes in Response to Lidocaine and Capsaicin Creams and tDCS
Pain rating on nocebo cream
|
8.54 units on a scale
Standard Deviation 3.54
|
8.80 units on a scale
Standard Deviation 2.60
|
9.01 units on a scale
Standard Deviation 2.75
|
|
Gracely Sensory Scale Pain Rating Changes in Response to Lidocaine and Capsaicin Creams and tDCS
Pain rating on placebo cream
|
7.29 units on a scale
Standard Deviation 2.74
|
6.41 units on a scale
Standard Deviation 2.86
|
7.38 units on a scale
Standard Deviation 2.84
|
|
Gracely Sensory Scale Pain Rating Changes in Response to Lidocaine and Capsaicin Creams and tDCS
Pain rating on neutral cream
|
8.10 units on a scale
Standard Deviation 2.65
|
7.96 units on a scale
Standard Deviation 2.90
|
7.88 units on a scale
Standard Deviation 2.56
|
Adverse Events
tDCS Enhancement
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
tDCS Inhibition
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Sham tDCS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
tDCS Enhancement
n=28 participants at risk
In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity.
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.
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.
|
tDCS Inhibition
n=30 participants at risk
In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity.
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.
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.
|
Sham tDCS
n=27 participants at risk
Sham 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 results of this study are due to tDCS or other reasons.
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.
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).
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Unpleasant tDCS Sensations
|
7.1%
2/28 • Number of events 2 • Up to 2 weeks for each participant (during participation in the study)
The occurrence of adverse events were assessed by study staff at each site visit. Adverse events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.00%
0/30 • Up to 2 weeks for each participant (during participation in the study)
The occurrence of adverse events were assessed by study staff at each site visit. Adverse events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.00%
0/27 • Up to 2 weeks for each participant (during participation in the study)
The occurrence of adverse events were assessed by study staff at each site visit. Adverse events were monitored/assessed without regard to the specific Adverse Event Term.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/28 • Up to 2 weeks for each participant (during participation in the study)
The occurrence of adverse events were assessed by study staff at each site visit. Adverse events were monitored/assessed without regard to the specific Adverse Event Term.
|
3.3%
1/30 • Number of events 1 • Up to 2 weeks for each participant (during participation in the study)
The occurrence of adverse events were assessed by study staff at each site visit. Adverse events were monitored/assessed without regard to the specific Adverse Event Term.
|
0.00%
0/27 • Up to 2 weeks for each participant (during participation in the study)
The occurrence of adverse events were assessed by study staff at each site visit. Adverse events were monitored/assessed without regard to the specific Adverse Event Term.
|
Additional Information
Jian Kong, Principal Investigator
Massachusetts General Hospital, Harvard Medical School
Phone: 617-726-7893
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place