High Definition Transcranial Direct Current Stimulation Motor Cortex Versus Insula

May 10, 2020 updated by: Saeid Metwaly Abouelyazid Elsawy, Assiut University

The Effects of High Definition Transcranial Direct Current Stimulation Over Primary Motor Cortex Versus Insular Cortical Targets on Experimental Capsaicin Induced Hyperalgesia and Pain in Healthy Volunteers

Brain stimulation is a technique that can alter cortical function and thus be suitable for treating pain. This is especially when pain is chronic and associated with functional and even structural reorganization of the central nervous system. The idea of using invasive and noninvasive brain stimulation for pain relief is not new. Studies from the 1950s have investigated the brain stimulation for therapeutic use. Direct implantation of electrodes on the cerebral cortex has been carried out by Tsubokawa and colleagues in Japan. Although reported to be effective, it is invasive and involves the implantation of a foreign body into the cranium. Recent advancements in the techniques of non-invasive brain stimulation have improved and have measurable modulatory effects making this an attractive alternative for treating pain

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Repetitive transcranial magnetic stimulation and transcranial direct current stimulation are currently the two main methods of non-invasive brain stimulation under investigation. Stimulation of the primary motor cortex has been reported to relieve neuropathic, musculoskeletal, visceral pain as well as headaches and migraine. Other parameters of stimulation have shown encouraging results. For example, stimulation of the secondary somatosensory cortex was also reported to relieve chronic visceral pain. However, there are numerous unanswered questions regarding these techniques.

This research project is an attempt to answer some of these questions:

  1. Which pain conditions can be alleviated by non-invasive brain stimulation?

  2. What are the best parameters for stimulation-

    1. method: transcranial direct current stimulation or repetitive transcranial magnetic stimulation transcranial or Alternating Current Stimulation
    2. High-Definition transcranial direct current stimulation or conventional transcranial direct current stimulation?
    3. which area to stimulate? Primary motor cortex, insula?
  3. Will other forms of treatment such as pharmacotherapy, peripheral nerve stimulation or multi-disciplinary pain management enhance the effectiveness of non-invasive brain stimulation

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Able to give informed consent to participate in the study.
  • Male and female University Undergraduate, Postgraduate and staff in the Department of Psychology.
  • American society of anesthesiology scores I to II patients.

Exclusion Criteria: the participant who has any history of:

  • an adverse reaction to brain stimulation.
  • a seizure
  • an unexplained loss of consciousness
  • a stroke
  • serious head injury
  • surgery to their head
  • any brain related, neurological illnesses
  • any illness that may have caused brain injury
  • frequent or severe headaches
  • metal in your head (outside the mouth) such as shrapnel, surgical clips, or fragments from welding
  • any implanted medical devices such as cardiac pacemaker's or medical pumps
  • taking any analgesic medications in the past 24 hours
  • pregnancy
  • anyone in your family has epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
SHAM_COMPARATOR: HD tDCS sham motor cortex
the intervention 10 participants will be subjected to1.5 gram of Capsaicin cream 0.075% concentration for 30 min then participants will be subjected to sham stimulation targeting motor cortex area using the high-definition transcranial direct current stimulation device by starting stimulation for 30 seconds then stop stimulation for 20 min
Device: HD tDCS sham motor cortex
the intervention 10 participants will be subjected to1.5 gram of Capsaicin cream 0.075% concentration for 30 min then participants will be subjected to sham stimulation targeting motor cortex area using the high-definition transcranial direct current stimulation device by starting stimulation for 30 seconds then stop stimulation for 20 min
Other: Capsaicin cream
Capsaicin cream
ACTIVE_COMPARATOR: HD tDCS active motor cortex
the intervention will be 10 participants will be subjected to 1.5-gram of Capsaicin cream 0.075 concentration for 30 min then participants will be subjected to active stimulation targeting motor cortex area with the high-definition transcranial direct current stimulation device with current intensity 2 milliampere for 20 min
Other: Capsaicin cream
Capsaicin cream
Device: HD tDCS active motor cortex
the intervention will be 10 participants will be subjected to 1.5-gram of Capsaicin cream 0.075 concentration for 30 min then participants will be subjected to active stimulation targeting motor cortex area with the high-definition transcranial direct current stimulation device with current intensity 2 milliampere for 20 min
ACTIVE_COMPARATOR: HD tDCS active insula cortex
the intervention will be 10 participants will be subjected to 1.5 gram of Capsaicin cream 0.075 concentration for 30 min then participants will be subjected to active stimulation targeting Insular cortex area with the high-definition transcranial direct current stimulation device, with current intensity 2milliampere for 20 min
Other: Capsaicin cream
Capsaicin cream
Device: HD tDCS active insula cortex
the intervention will be 10 participants will be subjected to 1.5 gram of Capsaicin cream 0.075 concentration for 30 min then participants will be subjected to active stimulation targeting Insular cortex area with the high-definition transcranial direct current stimulation device, with current intensity 2milliampere for 20 min

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain severity assessment using Numerical Rating Scale (NRS score from 0-100)
Time Frame: 30 min after capsaicin cream application and at the end of the HD tDCS session and one hour after study
we will put the capsaicin cream for 30 min at an area of 9 cm2 then we will assess the pain score throughout this time of application of the cream every 5 min
30 min after capsaicin cream application and at the end of the HD tDCS session and one hour after study

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
map area of sensitization caused by application of capsaicin cream
Time Frame: 30 min after the capsaicin cream application and at the end of HD tDCS sessionand one hour after study
The area of sensitization using calibrated Neurotip test using the spring mechanism which will exert a force of 40 gm so we will detect the change in sensation to the pin brick in the area of cream application
30 min after the capsaicin cream application and at the end of HD tDCS sessionand one hour after study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University College London Hospitals
Swansea University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 15, 2018

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 12, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RSO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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