Healthy VolunteersPhase 1tDCSHVNCT02125422
Neurophysiological Study of tDCS Effects in Healthy Volunteers
A Phase 1 study testing Cefaly tDCS in people with Healthy Volunteers, run by University of Liege at 1 site in Belgium.
Trial summary
Transcranial direct current stimulation is a tool to modulate cortical excitability. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cefaly tDCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2013to Apr 2014
- Phase
- Phase 1
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- age below 18 or above 65 years
- personal history of recurrent headache or other neurological diseases especially seizures,
- familial history of recurrent headache
- child migraine equivalents (motion sickness, cyclic vomiting or recurrent abdominal pain, somnambulism etc.. . .)
- chronic pain syndromes
- analgesics intake at the time of recording
- contra-indications to tDCS neurostimulation (metal prosthetics in the head or internal stimulation like a pacemaker).
Trial locations and contacts
1 site in 1 country.
About this study
Transcranial direct current stimulation is a tool to modulate cortical excitability.
Read the detailed description
Anodal transcranial direct currenti stimulation over visual cortex is able to decrease the thermo-nociceptive sensibility and thermonociceptive potentials, whilst cathodal transcranial direct current stimulation has the opposite effect, it decreases VEP amplitude and habituation. This neuromodulation technique is probably a tool in the prevention in episodic and chronic migraine.
The aim of the study is to study short and long term effect of tDCS over pain treshold, contact heat evoked potentials, blink reflex and visual evoked potentials in healthy volunteers.
- Conditions
- Healthy Volunteers
- Being tested
- Cefaly tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cefaly tDCSDevice
Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular anodal tDCS increases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.
| Study group | Role | What they receive |
|---|---|---|
| Cefaly tDCS | Experimental | Cathodal Cefaly tDCS is delivered over the visual cortex at 2 mA of intensity, for 20 minutes, for 5 consecutive days in 9 HV. The anode is placed over the left DLPFC.
2 mA anodal tDCS is delivered over the visual cortex, for 20 minutes, for 5 consecutive days in 9 HV Receives: Device: Cefaly tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurophysiological mesures changes
Modifications in neurophysiological test after direct current stimulation
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startNov 2013
- Primary completionDec 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean Schoenen, University of Liege
- Investigators
- Delphine Magis, MD, Principal investigator, University of LiegeJean Schoenen, MD, Principal investigator, University of Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125422
- Sponsor's protocol ID
- CB-1200
- Acronym
- tDCSHV
- Status last verified
- May 2015
- First submitted
- 18 Apr 2014
- Last updated
- 28 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Study of tDCS Effects in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02125422
- Acronym / sponsor ID
- tDCSHV / CB-1200
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 29 Apr 2014 (estimated)
- 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.
Transcranial direct current stimulation is a tool to modulate cortical excitability.
Detailed description
Anodal transcranial direct currenti stimulation over visual cortex is able to decrease the thermo-nociceptive sensibility and thermonociceptive potentials, whilst cathodal transcranial direct current stimulation has the opposite effect, it decreases VEP amplitude and habituation. This neuromodulation technique is probably a tool in the prevention in episodic and chronic migraine.
The aim of the study is to study short and long term effect of tDCS over pain treshold, contact heat evoked potentials, blink reflex and visual evoked potentials in healthy volunteers.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cefaly tDCS | Experimental | Device: Cefaly tDCSCathodal Cefaly tDCS is delivered over the visual cortex at 2 mA of intensity, for 20 minutes, for 5 consecutive days in 9 HV. The anode is placed over the left DLPFC. 2 mA anodal tDCS is delivered over the visual cortex, for 20 minutes, for 5 consecutive days in 9 HV |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (7 listed)
- age below 18 or above 65 years
- personal history of recurrent headache or other neurological diseases especially seizures,
- familial history of recurrent headache
- child migraine equivalents (motion sickness, cyclic vomiting or recurrent abdominal pain, somnambulism etc.. . .)
- chronic pain syndromes
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 |
|---|---|---|
| Cefaly tDCSCefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular anodal tDCS increases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias. | Device | Cefaly tDCS |
Primary outcome
Neurophysiological mesures changes
Time frame: up to 1 month
Modifications in neurophysiological test after direct current stimulation
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 28 May 2015.
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Screening Protocol
Pain
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.
Delphine Magis, MD principal investigator
University of Liege
Jean Schoenen, MD principal investigator
University of Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cefaly tDCS in people with Healthy Volunteers, run by University of Liege at 1 site in Belgium.
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 1 inclusion and 7 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 28 May 2015. 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 Belgium. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Neurophysiological mesures changes (time frame: up to 1 month). 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 28 May 2015.