Closed Loop TES for Enhancing Slow Wave Sleep

Overview

Compare closed-loop with open-loop application of TES to enhance slow waves of sleep.

Full Title of Study: “Improving Spatiotemporal Precision in Noninvasive Electrical Neuromodulation”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: January 14, 2021

Detailed Description

Note: FDA has determined that TES with the stimulus parameters as specified for this trial presents no significant risk, so that FDA clearance is not required. Several findings suggest that Transcranial Electrical Stimulation (TES) may be particularly effective if it is aligned with ongoing brain activity. One condition of the present research is an open-loop design, in which TES pulses (0.75 Hz pulses; 2.0 mA) are presented during slow wave sleep. The other condition is a closed-loop design, using identical pulses, but these will be phase aligned with the slow waves of sleep, measured by the electroencephalogram (EEG). The hypothesis is that closed-loop TES will be more effective in enhancing the amplitude and duration of slow wave sleep than open-loop TES.

Interventions

  • Device: Transcranial Electrical Neuromodulation (TES)
    • TES phase-aligned with slow waves or not

Arms, Groups and Cohorts

  • Active Comparator: Open-Loop
    • In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is not synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz.
  • Experimental: Closed-Loop
    • In this arm of this repeated measures (within subjects) design, the participants receive electrical neuromodulation (TES) that is synchronized to their slow waves of sleep. The Transcranial Electrical Stimulation (TES) is 2 mA applied in 100 ms pulses at 0.75 Hz.

Clinical Trial Outcome Measures

Primary Measures

  • Slow wave amplitude
    • Time Frame: Slow Wave Amplitude will be assessed during the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be slow wave amplitude expressed per minute of stage N3 sleep for the study night.
    • Amplitude of slow waves of sleep
  • Slow wave duration
    • Time Frame: Slow Wave Duration will be assessed in minutes for the night of sleep (defined as 8 hours). The dependent measure for the statistical test will be the duration (in minutes) of slow wave stage N3 sleep for the study night.
    • Duration of slow wave period in sleep

Participating in This Clinical Trial

Inclusion Criteria

  • healthy adults Exclusion Criteria:

  • persons with epilepsy

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Brain Electrophysiology Laboratory Company
  • Provider of Information About this Clinical Study
    • Principal Investigator: Don M. Tucker, CEO, Senior Scientist – Brain Electrophysiology Laboratory Company
  • Overall Contact(s)
    • Don M Tucker, PhD, 541-653-8266, don.tucker@belco.tech

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.