Pain Processing in Healthy VolunteersNCT04432363
Effects of tDCS in M1 and DLPFC on Pain Processing in Healthy Volunteers
A study testing Transcranial direct current stimulation in people with Pain Processing in Healthy Volunteers, run by Universidad Rey Juan Carlos at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effects of a direct current applied transcranial over two cortical areas on healthy volunteers' pain processing. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain Processing in Healthy Volunteers
- What is being tested?
- Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 6 Jun 2020to 25 Jul 2020
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40 years
- Comprehension of the study tasks
Who cannot join
- Presence of pain in the previous 6 months
- Altered sensitivity in the tested regions
- Intolerance to electrotherapy
- Presence of pacemakers or any other implanted device
- Ulcers or scars in the skin at the location of the electrodes
- Treatment with direct current stimulation within one week
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- Pregnancy
- Frequent headaches
- Epilepsy
- History of neuromuscular disease
- Previous clinical history of cervical surgery
- Injuries or surgery affecting the upper limb
- diabetes mellitus
- Cardiovascular diseases
- Oncological diseases
- Consumption of analgesic drugs 7 days before the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcranial Direct Current Stimulation on Primary Cortex and Prefrontal Dorsolateral Cortex in Pain Processing on Healthy Volunteers: A Triple Blind Randomized Controlled Trial.
The purpose of this study is to evaluate the effects of a direct current applied transcranial over two cortical areas on healthy volunteers' pain processing.
- Conditions
- Pain Processing in Healthy Volunteers
- Being tested
- Transcranial direct current stimulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulationDevice
Direct current application over the scalp to stimulate and change the excitability of the cortical areas underneath the electrodes (in this case left primary motor cortex and left dorsolateral prefrontal cortex).
| Study group | Role | What they receive |
|---|---|---|
| M1 stimulation | Active comparator | A 20 minutes 1mA direct current stimulation over left M1. Receives: Device: Transcranial direct current stimulation |
| M1+DLPFC stimulation | Active comparator | A 20 minutes 1mA direct current stimulation over left M1 and 1mA direct current stimulation over left DLPFC. Receives: Device: Transcranial direct current stimulation |
| Sham stimulation | Sham comparator | A 20 minutes sham stimulation where the device only is working first 30s and last 30s of the intervention and have a 10 seconds fade out in intensity at each ramp. Receives: Device: Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conditioned Pain Modulation
Pain pressure threshold change after a painful ischemic stimulus
Measured: Pre-intervention and immediately after treatment
Pain pressure algometer temporal summation
Change in pain perceived between the first and tenth painful pressure stimulus
Measured: Pre-intervention and immediately after treatment
Secondary outcomes (5)
Pain pressure threshold
Measurement of pressure applied until the perception of pain
Measured: Pre-intervention and immediately after treatment
Pain pressure tolerance
Measurement of maximal painful pressure tolerate using a pressure algometer
Measured: Pre-intervention and immediately after treatment
Neural mechanosensitivity
Measurement of range of motion achieved until the perception of tension
Measured: Pre-intervention and immediately after treatment
Cold hyperalgesia with a cold pack
Pain rated in a visual analogue scale after 10 seconds of a cold stimulus
Measured: Pre-intervention and immediately after treatment
Isometric grip strength
Maximal pressure achieved in a isometric gripping task
Measured: Pre-intervention and immediately after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start6 Jun 2020
- Primary completion25 Jul 2020
- Study completion25 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Processing in Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Crossover
- Model description
- Three groups cross over study with two intervention groups and one sham group.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Rey Juan Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josue Fernandez Carnero, Universidad Rey Juan Carlos
- Investigators
- Josue Fernandez Carnero, PhD, Study director, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04432363
- Sponsor's protocol ID
- 30012020204820
- Status last verified
- Oct 2020
- First submitted
- 9 Jun 2020
- Last updated
- 30 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcranial Direct Current Stimulation on Primary Cortex and Prefrontal Dorsolateral Cortex in Pain Processing on Healthy Volunteers: A Triple Blind Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT04432363
- Acronym / sponsor ID
- 30012020204820
- Conditions
- Pain Processing in Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universidad Rey Juan CarlosUniversity, hospital or other
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 25 Jul 2020 (actual)
- Study completion
- 25 Jul 2020 (actual)
- First posted
- 16 Jun 2020 (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.
The purpose of this study is to evaluate the effects of a direct current applied transcranial over two cortical areas on healthy volunteers' pain processing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Three groups cross over study with two intervention groups and one sham group.
| Arm | Type | Receives |
|---|---|---|
| M1 stimulation | Active comparator | Device: Transcranial direct current stimulationA 20 minutes 1mA direct current stimulation over left M1. |
| M1+DLPFC stimulation | Active comparator | Device: Transcranial direct current stimulationA 20 minutes 1mA direct current stimulation over left M1 and 1mA direct current stimulation over left DLPFC. |
| Sham stimulation | Sham comparator | Device: Transcranial direct current stimulationA 20 minutes sham stimulation where the device only is working first 30s and last 30s of the intervention and have a 10 seconds fade out in intensity at each ramp. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age between 18 and 40 years
- Comprehension of the study tasks
Key exclusion criteria (16 listed)
- Presence of pain in the previous 6 months
- Altered sensitivity in the tested regions
- Intolerance to electrotherapy
- Presence of pacemakers or any other implanted device
- Ulcers or scars in the skin at the location of the electrodes
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 |
|---|---|---|
| Transcranial direct current stimulationDirect current application over the scalp to stimulate and change the excitability of the cortical areas underneath the electrodes (in this case left primary motor cortex and left dorsolateral prefrontal cortex). | Device | M1 stimulation, M1+DLPFC stimulation, Sham stimulation |
Primary outcome
Conditioned Pain Modulation
Time frame: Pre-intervention and immediately after treatment
Pain pressure threshold change after a painful ischemic stimulus
Pain pressure algometer temporal summation
Time frame: Pre-intervention and immediately after treatment
Change in pain perceived between the first and tenth painful pressure stimulus
5 secondary outcomes
Pain pressure threshold
Time frame: Pre-intervention and immediately after treatment
Pain pressure tolerance
Time frame: Pre-intervention and immediately after treatment
Neural mechanosensitivity
Time frame: Pre-intervention and immediately after treatment
Cold hyperalgesia with a cold pack
Time frame: Pre-intervention and immediately after treatment
Isometric grip strength
Time frame: Pre-intervention and immediately after treatment
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 30 Oct 2020.
- Rey Juan Carlos UniversityLink provided by the sponsor.
- Individual participant dataSharing planned: No
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.
Josue Fernandez Carnero, PhD study director
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial direct current stimulation in people with Pain Processing in Healthy Volunteers, run by Universidad Rey Juan Carlos at 1 site in Spain.
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 2 inclusion and 16 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 30 Oct 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 Spain. 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?
Conditioned Pain Modulation (time frame: Pre-intervention and immediately after treatment). The study lists 2 primary outcomes in all. 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 30 Oct 2020.