NCT03298308

Brief Summary

This pilot study explored relationships between cranial electric stimulation and brainwave changes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 27, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 2, 2017

Completed
Last Updated

October 2, 2017

Status Verified

September 1, 2017

Enrollment Period

12 months

First QC Date

September 20, 2017

Last Update Submit

September 26, 2017

Conditions

Psychiatric Disorder

Outcome Measures

Primary Outcomes (1)

  • Quantitative EEG Analysis

    The investigators used a commercially available EEG headset (Neurosky MindSet) in combination with EEG software (SmartMind) to obtain and analyze the Quantitative EEG from the subjects. The combination of the EEG headset with the software identified the five brainwave frequencies that are clinically relevant in studying EEG activity: Alpha, Beta, Delta, Gamma, and Theta. The combination of the headset and software reported changes in brainwave amplitude in microvolts for each brainwave frequency. Alpha waves increase with relaxation and drowsiness; and Beta waves, increase with wakefulness and concentration. Delta and Theta waves increase during meditative states and Gamma may suggest brain synchronicity.

    Quantitative EEG collected at baseline (immediately before stimulation), immediately after 20 minutes of stimulation and then 5 and 10 minutes post stimualtion. Each of these four measures will record 30 seconds of brainwave activity

Study Arms (1)

Brainwave

EXPERIMENTAL

Brainwave analysis after cranial electric stimulation

Device: Cranial Electric Stimulation

Interventions

Cranial Electric StimulationDEVICE

Micro amperage TCDS

Brainwave

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Subjects will be excluded who have a seizure disorder, a cardiac pacemaker, or active untreated vertigo.
  • Subjects will be excluded if they have used CES the day of the study. However, they may participate in the study the following day.
  • Female subjects who are or who suspect they may be pregnant.
  • Subjects will also be excluded who are clinically judged by the investigators to be actively suicidal or have another psychiatric condition that would require inpatient hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lande RG, Gragnani CT. Prospective Study of Brain Wave Changes Associated With Cranial Electrotherapy Stimulation. Prim Care Companion CNS Disord. 2018 Jan 18;20(1):17m02214. doi: 10.4088/PCC.17m02214.

    PMID: 29360291DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2017

First Posted

October 2, 2017

Study Start

May 27, 2016

Primary Completion

May 10, 2017

Study Completion

May 10, 2017

Last Updated

October 2, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share