PainNCT03102710

Neuromodulation of Lidocaine and Capsaicin Cream Effects on Pain Experience

A study testing transcranial direct current stimulation (tDCS), Lidocaine cream and Capsaicin cream in people with Pain, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 21 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Pain
What is being tested?: transcranial direct current stimulation (tDCS), Lidocaine cream and Capsaicin cream
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 103 participants
Where: 1 siteUnited States
Study dates: May 2016to Mar 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Charlestown, Massachusetts, 02129

Other trials in United States

About this study

Official title: Neuromodulation of Placebo and Nocebo Effects

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.

Conditions: Pain
Being tested: transcranial direct current stimulation (tDCS), Lidocaine cream, Capsaicin cream, Control cream
Medical subject headings: Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

transcranial direct current stimulation (tDCS)Device
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 creamOther
Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).
Capsaicin creamOther
Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).
Control creamOther
A neutral cream will be applied on the arm as a control.

Study groups in NCT03102710
Study group	Role	What they receive
tDCS Enhancement	Experimental	In this group, the transcranial direct current stimulation (tDCS) stimulates the areas of the brain being examined in this study to increase their activity. Receives: Device: transcranial direct current stimulation (tDCS); Other: Lidocaine cream; Other: Capsaicin cream; Other: Control cream
tDCS Inhibition	Experimental	In this group, the transcranial direct current stimulation (tDCS) inhibits the areas of the brain being examined in this study to decrease their activity. Receives: Device: transcranial direct current stimulation (tDCS); Other: Lidocaine cream; Other: Capsaicin cream; Other: Control cream
Sham tDCS	Sham comparator	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 the results of this study are due to the tDCS or other reasons. Receives: Device: transcranial direct current stimulation (tDCS); Other: Lidocaine cream; Other: Capsaicin cream; Other: Control cream

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: up to 2 weeks

Secondary outcomes (1)

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.
Measured: up to 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2016Mar 2019

First posted6 Apr 2017
Study startMay 2016
Primary completionMar 2019
Study completionMar 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 103 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03102710
Sponsor's protocol ID: 2015P000685
Status last verified: Jun 2020
First submitted: 27 Jan 2017
Last updated: 7 Jul 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Neuromodulation of Placebo and Nocebo Effects
ClinicalTrials.gov ID: NCT03102710
Acronym / sponsor ID: 2015P000685
Conditions: Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 103 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: May 2016 (actual)
Primary completion: Mar 2019 (actual)
Study completion: Mar 2019 (actual)
First posted: 6 Apr 2017 (actual)
Results: Posted 7 Jul 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
tDCS Enhancement	Experimental	Device: transcranial direct current stimulation (tDCS), Other: Lidocaine cream, Other: Capsaicin cream, Other: Control creamIn 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	Experimental	Device: transcranial direct current stimulation (tDCS), Other: Lidocaine cream, Other: Capsaicin cream, Other: Control creamIn 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 comparator	Device: transcranial direct current stimulation (tDCS), Other: Lidocaine cream, Other: Capsaicin cream, Other: Control creamSham 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.

Who may qualify

Ages: 21 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Sham tDCS, tDCS Enhancement, tDCS Inhibition
Lidocaine creamLidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).	Other	Sham tDCS, tDCS Enhancement, tDCS Inhibition
Capsaicin creamCapsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).	Other	Sham tDCS, tDCS Enhancement, tDCS Inhibition
Control creamA neutral cream will be applied on the arm as a control.	Other	Sham tDCS, tDCS Enhancement, tDCS Inhibition

Primary outcome

Comparison of Functional Connectivity Changes of the DLPFC Before and After tDCS Stimulation
Time frame: up to 2 weeks
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.
fMRI Resting States Functional Connectivity Changes During Pain Stimulation
Time frame: up to 2 weeks
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.

1 secondary outcome

Gracely Sensory Scale Pain Rating Changes in Response to Lidocaine and Capsaicin Creams and tDCS
Time frame: up to 2 weeks

Results and safety

Results posted to the registry on 7 Jul 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
tDCS Enhancement	28	27
tDCS Inhibition	30	27
Sham tDCS	27	27

Primary outcome: Comparison of Functional Connectivity Changes of the DLPFC Before and After tDCS Stimulation

Time frame: up to 2 weeks. Mean (Standard Deviation). Unit: Fisher Z value

Measure	tDCS Enhancement n = 27	tDCS Inhibition n = 27	Sham tDCS n = 27
rDLPFC-SMA Functional Connectivity (post-pre)	-0.11 (0.22)	-0.09 (0.16)	0.08 (0.20)
rDLPFC-Insula Functional Connectivity (post-pre)	-0.13 (0.23)	-0.13 (0.20)	0.07 (0.18)

Population analysed: Participants who completed all study sessions

Primary outcome: fMRI Resting States Functional Connectivity Changes During Pain Stimulation

Time frame: up to 2 weeks. Mean (Standard Deviation). Unit: Arbitrary unit

Measure	tDCS Enhancement n = 26	tDCS Inhibition n = 27	Sham tDCS n = 26
BOLD activity change in mPFC/ACC: placebo contrast	0.14 (0.47)	0.50 (0.57)	-0.17 (0.68)
BOLD activity change in mPFC/ACC: nocebo contrast	0.26 (0.80)	0.27 (0.81)	0.25 (1.15)
BOLD activity in the left insula: placebo contrast	0.11 (0.35)	0.21 (0.81)	0.18 (0.64)
BOLD activity in the left insula: nocebo contrast	0.08 (0.36)	0.16 (0.35)	0.30 (0.39)

Population analysed: Participants who completed all study sessions and whose task fMRI data had no issues.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Up to 2 weeks for each participant (during participation in the study). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
tDCS Enhancement	0 of 28 (0%)	2 of 28 (7.1%)	0 of 28
tDCS Inhibition	0 of 30 (0%)	1 of 30 (3.3%)	0 of 30
Sham tDCS	0 of 27 (0%)	0 of 27 (0%)	0 of 27

Limitations and caveats (from the sponsor): The sample size for this study was relatively small.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jian Kong principal investigator

MGH

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing transcranial direct current stimulation (tDCS), Lidocaine cream and Capsaicin cream in people with Pain, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Comparison of Functional Connectivity Changes of the DLPFC Before and After tDCS Stimulation (time frame: up to 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03102710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.