Inter-individual VariabilityNCT03293316
Using Electroencephalography (EEG) and Transcranial Current Stimulation (tCS) to Study and Modulate Cognition Study
A study testing Transcranial Random Noise Stimulation in people with Inter-individual Variability, run by University of Oxford.
Trial summary
Inter-individual variability in responsiveness to interventions poses great challenges for translational neuroscience, and health care in general. The investigations sought to examine the potential for high-frequency transcranial random noise stimulation (tRNS) to modulate sustained attention in a manner that was… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Inter-individual Variability
- What is being tested?
- Transcranial Random Noise Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Oct 2016
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-35 years
Who cannot join
- Left-handedness
- Visual impairment
- History of fainting,
- History of neurological or psychiatric illness,
- Neurological insult
- Drug or alcohol abuse
- Reporting current use of anti- psychotic or anti-depressant medications
About this study
Inter-individual variability in responsiveness to interventions poses great challenges for translational neuroscience, and health care in general. The investigations sought to examine the potential for high-frequency transcranial random noise stimulation (tRNS) to modulate sustained attention in a manner that was informed by individual differences in EEG indices.
Read the detailed description
Inter-individual variability in responsiveness to interventions poses great challenges for translational neuroscience, and health care in general. Reliable and cost- effective screening procedures that can identify individuals who are more likely to benefit from an intervention could have substantial real-world benefits. Here, the investigators sought to examine the potential for high-frequency transcranial random noise stimulation (tRNS) to modulate sustained attention in a manner that was informed by individual differences in a well-studied electrocortical marker, spontaneous theta/beta ratio. The investigators hypothesized that individuals with relatively high theta/beta ratios, putatively reflecting suboptimal cortical arousal, would be more likely to benefit from the gains in cortical excitability afforded by tRNS. Seventy-two young healthy adults were administered 1mA, 2mA and sham tRNS in a double-blind, randomised, cross-over manner, while they performed a continuous monitoring paradigm. Electroencephalography was acquired before and after each stimulation condition.
This approach may constitute a feasible means of using individual differences in neurophysiology to inform predictions about outcomes from targeted cognitive interventions.
- Conditions
- Inter-individual Variability
- Being tested
- Transcranial Random Noise Stimulation
- Keywords
- Transcranial electrical stimulation; random noise;, cognitive interventions; electroencephalography;, inter-individual variability; stochastic resonance;
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Random Noise StimulationDevice
Also called Starstim; Neuroelectrics
The transcranial random noise stimulation was delivered using a StarStim device (Neuroelectrics®, Barcelona, Spain). The electrodes were encased in a pair of saline-soaked sponges (25 cm2 ), and were secured within a Neurolectrics EEG cap over right DLPFC (F4) and right IPL (P4), according to the 10-20 international EEG system. Other details are stated under the 'intervention arm' descriptions.
| Study group | Role | What they receive |
|---|---|---|
| Sham Transcranial Random Noise Stimulation | Sham comparator | The sham tRNS condition involves 30 seconds of 1.5 mA tRNS, with a ramping period of 30 seconds at the onset and offset. This procedure ensures that, in both the Active and Sham conditions, participants experience the sensations associated with the onset of transcranial electrical stimulation (e.g., tingling sensation) Receives: Device: Transcranial Random Noise Stimulation |
| 1mA Transcranial Random Noise Stimulation | Experimental | The 1mA tRNS condition consists of 1 mA peak-to-peak (-.5 mA to .5 mA) high frequency noise (100-500 Hz), with amplitude values that are normally distributed and have a mean of zero. The stimulation is delivered for 20 minutes, with a ramping period of 30 seconds at the onset and offset. Receives: Device: Transcranial Random Noise Stimulation |
| 2mA Transcranial Random Noise Stimulation | Experimental | The only factor that varies for the 2mA tRNS condition is that the high frequency noise has a peak-to-peak of -1 mA to 1mA as opposed to -.5 mA to .5 mA. Again, the stimulation is delivered for 20 minutes, with a ramping period of 30 seconds at the onset and offset. Receives: Device: Transcranial Random Noise Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography
Voltage readings from the scalp
Measured: 4 minutes
Secondary outcomes (1)
Sustained Attention performance
Sustained Attention performance was defined as response time variability on a continuous monitoring paradigm
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study startNov 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inter-individual VariabilityStudies of the same condition, open and under way.
- More trials run by University of OxfordThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293316
- Sponsor's protocol ID
- C2-2014-033
- Status last verified
- Sep 2017
- First submitted
- 21 Sep 2017
- Last updated
- 3 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Electroencephalography (EEG) and Transcranial Current Stimulation (tCS) to Study and Modulate Cognition Study
- ClinicalTrials.gov ID
- NCT03293316
- Acronym / sponsor ID
- C2-2014-033
- Conditions
- Inter-individual Variability
- Keywords
- Transcranial electrical stimulation; random noise;, cognitive interventions; electroencephalography;, inter-individual variability; stochastic resonance;
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Nov 2015 (actual)
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Sep 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.
Inter-individual variability in responsiveness to interventions poses great challenges for translational neuroscience, and health care in general. The investigations sought to examine the potential for high-frequency transcranial random noise stimulation (tRNS) to modulate sustained attention in a manner that was informed by individual differences in EEG indices.
Detailed description
Inter-individual variability in responsiveness to interventions poses great challenges for translational neuroscience, and health care in general. Reliable and cost- effective screening procedures that can identify individuals who are more likely to benefit from an intervention could have substantial real-world benefits. Here, the investigators sought to examine the potential for high-frequency transcranial random noise stimulation (tRNS) to modulate sustained attention in a manner that was informed by individual differences in a well-studied electrocortical marker, spontaneous theta/beta ratio. The investigators hypothesized that individuals with relatively high theta/beta ratios, putatively reflecting suboptimal cortical arousal, would be more likely to benefit from the gains in cortical excitability afforded by tRNS. Seventy-two young healthy adults were administered 1mA, 2mA and sham tRNS in a double-blind, randomised, cross-over manner, while they performed a continuous monitoring paradigm. Electroencephalography was acquired before and after each stimulation condition.
This approach may constitute a feasible means of using individual differences in neurophysiology to inform predictions about outcomes from targeted cognitive interventions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sham Transcranial Random Noise Stimulation | Sham comparator | Device: Transcranial Random Noise StimulationThe sham tRNS condition involves 30 seconds of 1.5 mA tRNS, with a ramping period of 30 seconds at the onset and offset. This procedure ensures that, in both the Active and Sham conditions, participants experience the sensations associated with the onset of transcranial electrical stimulation (e.g., tingling sensation) |
| 1mA Transcranial Random Noise Stimulation | Experimental | Device: Transcranial Random Noise StimulationThe 1mA tRNS condition consists of 1 mA peak-to-peak (-.5 mA to .5 mA) high frequency noise (100-500 Hz), with amplitude values that are normally distributed and have a mean of zero. The stimulation is delivered for 20 minutes, with a ramping period of 30 seconds at the onset and offset. |
| 2mA Transcranial Random Noise Stimulation | Experimental | Device: Transcranial Random Noise StimulationThe only factor that varies for the 2mA tRNS condition is that the high frequency noise has a peak-to-peak of -1 mA to 1mA as opposed to -.5 mA to .5 mA. Again, the stimulation is delivered for 20 minutes, with a ramping period of 30 seconds at the onset and offset. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Aged 18-35 years
Key exclusion criteria (7 listed)
- Left-handedness
- Visual impairment
- History of fainting,
- History of neurological or psychiatric illness,
- Neurological insult
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 Random Noise StimulationAlso: Starstim; NeuroelectricsThe transcranial random noise stimulation was delivered using a StarStim device (Neuroelectrics®, Barcelona, Spain). The electrodes were encased in a pair of saline-soaked sponges (25 cm2 ), and were secured within a Neurolectrics EEG cap over right DLPFC (F4) and right IPL (P4), according to the 10-20 international EEG system. Other details are stated under the 'intervention arm' descriptions. | Device | 1mA Transcranial Random Noise Stimulation, 2mA Transcranial Random Noise Stimulation, Sham Transcranial Random Noise Stimulation |
Primary outcome
Electroencephalography
Time frame: 4 minutes
Voltage readings from the scalp
1 secondary outcome
Sustained Attention performance
Time frame: 20 minutes
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 3 Oct 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Random Noise Stimulation in people with Inter-individual Variability, run by University of Oxford.
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 3 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Electroencephalography (time frame: 4 minutes). 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 3 Oct 2017.