Neuromodulation of Lidocaine and Capsaicin Cream Effects on Pain Experience
NCT ID: NCT03102710
Last Updated: 2020-07-07
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
103 participants
INTERVENTIONAL
2016-05-31
2019-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Theta Burst Brain Stimulation in Diabetic Neuropathy Patients With Neuropathic Pain: Investigating Neural Mechanisms
NCT04988321
Effects of Lidocaine Patch on Intradermal Capsaicin Induced Pain and Hyperalgesia
NCT00373893
The Effect of Transcranial Direct Current Stimulation (t-DCS) On the P300 Component of Event-Related Potentials in Patients With Chronic Neuropathic Pain Due To CRPS or Diabetic Neuropathy
NCT00815932
Long-term Effect of Motor Cortex Stimulation in Patients Suffering From Chronic Neuropathic Pain
NCT03189823
IV Lidocaine Infusion for Neuropathic Pain
NCT05731739
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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 the results of this study are due to the 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).
Control cream
A neutral cream will be applied on the arm as a control.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
21 Years
50 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Massachusetts General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Jian Kong
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jian Kong
Role: PRINCIPAL_INVESTIGATOR
MGH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Massachusetts General Hospital
Charlestown, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Informed Consent Form
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015P000685
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.