PainNCT03216707
High Definition Transcranial Direct Current Stimulation Motor Cortex Versus Insula
A study testing HD tDCS active motor cortex, HD tDCS active insula cortex and Capsaicin cream in people with Pain, run by Assiut University at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- HD tDCS active motor cortex, HD tDCS active insula cortex and Capsaicin cream
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2017to 15 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- an adverse reaction to brain stimulation.
- a seizure
- an unexplained loss of consciousness
- a stroke
- serious head injury
- surgery to their head
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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:
- Which pain conditions can be alleviated by non-invasive brain stimulation?
- What are the best parameters for stimulation-
- method: transcranial direct current stimulation or repetitive transcranial magnetic stimulation transcranial or Alternating Current Stimulation
- High-Definition transcranial direct current stimulation or conventional transcranial direct current stimulation?
- which area to stimulate? Primary motor cortex, insula?
- Will other forms of treatment such as pharmacotherapy, peripheral nerve stimulation or multi-disciplinary pain management enhance the effectiveness of non-invasive brain stimulation
- Conditions
- Pain
- Being tested
- HD tDCS active motor cortex, HD tDCS active insula cortex, HD tDCS sham motor cortex, Capsaicin cream
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HD tDCS active motor cortexDevice
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 cortexDevice
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 sham motor cortexDevice
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
Capsaicin creamOther
Capsaicin cream
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: HD tDCS active insula cortex; Other: Capsaicin cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
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
Measured: 30 min after the capsaicin cream application and at the end of HD tDCS sessionand one hour after study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start1 Sep 2017
- Primary completion15 Jun 2018
- Study completion15 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Collaborators
- Swansea University, University College London Hospitals
- Responsible party
- Principal investigator, Saeid Metwaly Abouelyazid Elsawy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216707
- Sponsor's protocol ID
- RSO
- Status last verified
- May 2020
- First submitted
- 6 Jul 2017
- Last updated
- 12 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03216707
- Acronym / sponsor ID
- RSO
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Collaborators
- Swansea University, University College London Hospitals
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Which pain conditions can be alleviated by non-invasive brain stimulation?
- What are the best parameters for stimulation-
- method: transcranial direct current stimulation or repetitive transcranial magnetic stimulation transcranial or Alternating Current Stimulation
- High-Definition transcranial direct current stimulation or conventional transcranial direct current stimulation?
- which area to stimulate? Primary motor cortex, insula?
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| HD tDCS sham motor cortex | Sham comparator | Device: HD tDCS sham motor cortex, Other: Capsaicin creamthe 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 | Active comparator | Device: HD tDCS active motor cortex, Other: Capsaicin creamthe 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 | Active comparator | Device: HD tDCS active insula cortex, Other: Capsaicin creamthe 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- an adverse reaction to brain stimulation.
- a seizure
- an unexplained loss of consciousness
- a stroke
- serious head injury
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 |
|---|---|---|
| HD tDCS active motor cortexthe 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 |
| HD tDCS active insula cortexthe 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 |
| HD tDCS sham motor cortexthe 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 |
| Capsaicin creamCapsaicin cream | Other | HD tDCS active insula cortex, HD tDCS active motor cortex, HD tDCS sham motor cortex |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HD tDCS active motor cortex, HD tDCS active insula cortex and Capsaicin cream in people with Pain, run by Assiut University at 1 site in United Kingdom.
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 14 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 12 May 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 Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2020.