Cerebral Excitability and Cognitive Performance

Cognitive Change Clinical Trial

Official title:

Cerebral Excitability and Cognitive Performance

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03807934
• Other study ID #: 1303018
• Status: Enrolling by invitation
• Phase: N/A
• Start date: April 15, 2013
• Est. completion date: April 14, 2023

Study information

• Verified date: April 2021
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates the perceptual and cognitive influences of low-intensity electrical brain stimulation (transcranial direct current stimulation; tDCS), versus control (sham) conditions.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1500
• Est. completion date: April 14, 2023
• Est. primary completion date: April 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Between ages of 18-65.

Exclusion Criteria:

• History of adverse reaction to tDCS (trans-cranial direct current stimulation).

• History of seizure activity.

• History of head injury (including neurosurgery).

• History of illness causing brain injury.

• History of other brain-related condition (such as traumatic brain injury).

• History of diagnosis with a neurological or psychiatric disorder.

• History of metal in head (outside of mouth), such as shrapnel, surgical clips, or fragments from welding or metalwork.

• History of sensitive scalp.

Related Conditions & MeSH terms

• Cognitive Change

Intervention

Other:
• Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems
Active (at or below 2mA) versus sham (at or below 0.5mA) stimulation targeting brain regions engaged during verbal and/or spatial perceptual and cognitive processing. Brain stimulation devices are not currently regulated by the United States Food and Drug Administration. Local IRB has determined the devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure.

Locations

Country	Name	City	State
United States	Tufts University	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

References & Publications (5)

Brunyé TT, Holmes A, Cantelon J, Eddy MD, Gardony AL, Mahoney CR, Taylor HA. Direct current brain stimulation enhances navigation efficiency in individuals with low spatial sense of direction. Neuroreport. 2014 Oct 22;25(15):1175-9. doi: 10.1097/WNR.00000 — View Citation

Brunyé TT, Hussey EK, Fontes EB, Ward N. Modulating Applied Task Performance via Transcranial Electrical Stimulation. Front Hum Neurosci. 2019 Apr 30;13:140. doi: 10.3389/fnhum.2019.00140. eCollection 2019. Review. — View Citation

Brunyé TT, Moran JM, Cantelon J, Holmes A, Eddy MD, Mahoney CR, Taylor HA. Increasing breadth of semantic associations with left frontopolar direct current brain stimulation: a role for individual differences. Neuroreport. 2015 Mar 25;26(5):296-301. doi: — View Citation

Brunyé TT, Smith AM, Horner CB, Thomas AK. Verbal long-term memory is enhanced by retrieval practice but impaired by prefrontal direct current stimulation. Brain Cogn. 2018 Dec;128:80-88. doi: 10.1016/j.bandc.2018.09.008. Epub 2018 Nov 8. — View Citation

Brunyé TT. Modulating Spatial Processes and Navigation via Transcranial Electrical Stimulation: A Mini Review. Front Hum Neurosci. 2018 Jan 9;11:649. doi: 10.3389/fnhum.2017.00649. eCollection 2017. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual perceptual performance	Ability to accurately and efficiently perceive perceptual information, including threat detection, local contrast gradient detection, face memory, and intent appraisal. All are computerized tasks.	36 weeks
Primary	Verbal cognitive performance	Ability to accurately and efficiently process verbal information, including verbal cued free association tasks, verbal long-term memory, and language comprehension. All are computerized tasks.	36 weeks
Primary	Spatial cognitive performance	Ability to accurately and efficiently process spatial information, including map learning, virtual urban navigation, and mental rotation. All are computerized tasks.	72 weeks