High Definition Transcranial Direct Current Stimulation Motor Cortex Versus Insula

Not Applicable

Completed

• Conditions: Pain
• Interventions: Device: HD tDCS sham motor cortex; Device: HD tDCS active motor cortex; Device: HD tDCS active insula cortex; Other: Capsaicin cream

• Registration Number: NCT03216707
• Lead Sponsor: Assiut University

Brief Summary

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

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

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-13
• Study Start: 2017-09-01
• Primary Completion: 2018-06-15
• Study Completion: 2018-06-15
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-10
• Last Update Posted: 2020-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HD tDCS sham motor cortex	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
HD tDCS active insula cortex	Capsaicin cream	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
HD tDCS active motor cortex	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
HD tDCS sham motor cortex	Capsaicin cream	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
HD tDCS active motor cortex	Capsaicin cream	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
HD tDCS active insula cortex	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

Primary Outcome Measures

Name	Time	Method
Pain severity assessment using Numerical Rating Scale (NRS score from 0-100)	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

Secondary Outcome Measures

Name	Time	Method
map area of sensitization caused by application of capsaicin cream	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

Trial Locations

Locations (1)

Saeid Elsawy; 🇬🇧 London, United Kingdom