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

NCT03293316 | Completed

• 1 other identifier: C2-2014-033
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inter-individual Variability

Keywords

Transcranial electrical stimulation; random noise;; cognitive interventions; electroencephalography;; inter-individual variability; stochastic resonance;

Outcome Measures

Primary Outcomes (1)

• Electroencephalography

  Voltage readings from the scalp

  4 minutes

Secondary Outcomes (1)

• Sustained Attention performance

  20 minutes

Study Arms (3)

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)

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.

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.

Device: Transcranial Random Noise Stimulation

Interventions

Transcranial Random Noise Stimulation 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.

Also known as: Starstim; Neuroelectrics

1mA Transcranial Random Noise Stimulation; 2mA Transcranial Random Noise Stimulation; Sham Transcranial Random Noise Stimulation

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Aged 18-35 years

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead

MeSH Terms

Interventions

Transcranial Direct Current Stimulation

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized Double-Blind
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2017
• First Posted: September 26, 2017
• Study Start: November 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: October 1, 2016
• Last Updated: October 3, 2017

Record last verified: 2017-09