High Definition Transcranial Direct Current Stimulation Motor Cortex Versus Insula

NCT03216707 | Completed

• 1 other identifier: RSO
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

• Pain severity assessment using Numerical Rating Scale (NRS score from 0-100)

  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 Outcomes (1)

• 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

Study Arms (3)

HD tDCS sham motor cortex

SHAM COMPARATOR

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; Other: Capsaicin cream

HD tDCS active motor cortex

ACTIVE COMPARATOR

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

Device: HD tDCS active motor cortex; Other: Capsaicin cream

HD tDCS active insula cortex

ACTIVE COMPARATOR

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

Device: HD tDCS active insula cortex; Other: Capsaicin cream

Interventions

HD tDCS active motor cortex DEVICE

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 motor cortex

HD tDCS active insula cortex DEVICE

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 insula cortex

HD tDCS sham motor cortex DEVICE

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 sham motor cortex

Capsaicin cream OTHER

Capsaicin cream

HD tDCS active insula cortex; HD tDCS active motor cortex; HD tDCS sham motor cortex

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead
• Swansea University: collaborator
• University College London Hospitals: collaborator

Study Sites (1)

Saeid Elsawy

London, N15 4DW, United Kingdom

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 13, 2017
• Study Start: September 1, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: May 12, 2020

Record last verified: 2020-05

Locations

GB (1)