Using Electroencephalography (EEG) and Transcranial Current Stimulation (tCS) to Study and Modulate Cognition Study

NCT ID: NCT03293316

Last Updated: 2017-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2016-10-31

Brief 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 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.

Conditions

Inter-individual Variability

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Sham Transcranial Random Noise Stimulation

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)

Group Type: SHAM_COMPARATOR

Transcranial Random Noise Stimulation

Intervention Type: DEVICE

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.

1mA Transcranial Random Noise Stimulation

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.

Group Type: EXPERIMENTAL

Transcranial Random Noise Stimulation

Intervention Type: DEVICE

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.

2mA Transcranial Random Noise Stimulation

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.

Group Type: EXPERIMENTAL

Transcranial Random Noise Stimulation

Intervention Type: DEVICE

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.

Interventions

Transcranial Random Noise Stimulation

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.

Intervention Type: DEVICE

Other Intervention Names

Starstim; Neuroelectrics

Eligibility Criteria

Inclusion Criteria

• Aged 18-35 years

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

C2-2014-033

Identifier Type: -

Identifier Source: org_study_id