NCT04344470

Brief Summary

Background: 'Free will' can be defined as the belief that people have control over their thoughts and movements. The topic of free will is controversial and is still being debated. Science has only partial answers to questions about free will, so researchers want to learn more about it. They want to assess the role of consciousness when intentions are present with behavior. This could help to explain the causal role of consciousness in movement or decisions. Objective: To learn more about free will. Eligibility: Healthy, right-handed adults ages 25-45 Design: Participants will be screened with medical history, physical exam, and neurological exam. Participants will have 1 study visit. It will last up to 4 hours. Participants will sit in a comfortable chair in front of a screen. They will perform some or all of the following tasks. Visual Task. Participants will watch different stimuli on the screen and answer simple questions. Electroencephalography (EEG). An EEG records the electrical activity of the brain ('brain waves'). For the EEG, small electrodes are put on the scalp with an electrode cap. A gel is placed in the space between the electrodes and the scalp. Participants' brain waves will be recorded, including while they decide whether to move their thumb. Choice/Reaction Time Task. Participants will watch different stimuli on the screen and react to them by moving their wrist. During this task, they will wear an EEG cap on their head and electrodes on their arms and wrists. Electromyography. Small electrodes will be attached to participants' skin. Their muscle activity will be recorded while they decide whether to move their wrist and during the movement itself. Transcranial Magnetic Stimulation (TMS): TMS is a non-invasive brain stimulation that uses magnetic field to stimulate nerve cells in your brain. TMS can increase or decrease brain activity in particular area of your brain. TMS operates completely outside of the body and is generally very well tolerated....

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 11, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 14, 2020

Completed
8 months until next milestone

Study Start

First participant enrolled

December 22, 2020

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 26, 2023

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 21, 2024

Completed
Last Updated

April 5, 2024

Status Verified

March 21, 2024

Enrollment Period

2.5 years

First QC Date

April 11, 2020

Last Update Submit

April 4, 2024

Conditions

Keywords

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • Experiment1: Identification of the best characteristics that allow us to create a backward masking effect of the second stimulus on the first one.

    We will develop a methodological approach to create the best backward masking effect. We will ask the subjects what they saw, to prove the effectiveness of the backward masking.

    throughout

  • Experiment 2: Reaction time and accuracies of the responses to different stimuli (symbols, faces, objects, etc.) in different conditions (with and without masking)

    Subjects will move to the first stimulus even if unseen. We want to study subjects behavior in different conditions (simple reaction task, choice reaction task, with and without masking) with different stimuli (symbols, faces, objects, etc.). Furthermore, we want to analyze the EEG (classic ERP, microstates, etc.) related to those stimuli. EEG will be also analyzed to study the nature and strength of the visual pathway for movement and the pathway for visual perception at rest.

    throughout

  • Experiment 1: Identification of the EEG characteristic or ERP shape related to different stimuli and the brain region origin.

    We will create a template of the shape of the ERP and the characteristics of EEG related to different stimuli to be identified in the second sub-study.

    throughout

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

Healthy Volunteers

Device: EMGDevice: EEG

Interventions

EMGDEVICE

EMG will be recorded from two electrodes placed on both extensor carpi radialis (ECR) muscles

Healthy Volunteers
EEGDEVICE

EEG electrodes will be positioned according to 10-20 International System, with every impedance kept under 5 kOhm. EEG data will be amplified, filtered (DC-100 Hz), digitized at 1000 Hz, and stored on a computer for offline analysis.

Healthy Volunteers

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • In order to be eligible to participate in this study, an individual must meet all of the following criteria:
  • Age between 25-45 years
  • Right-handed (tested by the Edinburg handedness inventory).
  • Able to give informed consent.
  • Able to comply with all study procedures.
  • Fluent in English.

You may not qualify if:

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Illegal drug use within the past 6 months based on history alone. The intent is to exclude those with drug use that may affect study results.
  • Self-reported consumption of \>14 alcoholic drinks/week for a man and \>7 alcoholic drinks/week for a woman.
  • Abnormal findings on neurological examination.
  • History of current brain tumor, stroke, head trauma with loss of consciousness, epilepsy, or seizures.
  • Current episode of major depression or any major psychiatric illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Links

MeSH Terms

Interventions

Electroencephalography

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Lauren B Reoma, M.D.

    National Institute of Neurological Disorders and Stroke (NINDS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2020

First Posted

April 14, 2020

Study Start

December 22, 2020

Primary Completion

June 26, 2023

Study Completion

March 21, 2024

Last Updated

April 5, 2024

Record last verified: 2024-03-21

Locations