Modulating Human Cortical Plasticity With Transcranial Electrical Stimulation

NCT03114488 | Completed Results DMC FDA Device

• 1 other identifier: 1703M09401
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Experience dependent plasticity is a fundamental property of the brain. It allows neural systems to adapt in response to environmental input and subserves the vital functions of learning and memory. Deficits in plasticity are also thought play a causal role in the pathophysiology of several psychiatric disorders, specifically schizophrenia (SZ). Treatments that can probe or even enhance plasticity have potential to be of great clinical and research value. Non-invasive neuromodulation via transcranial direct current stimulation (tDCS) is a promising method for modulating neural plasticity. tDCS delivers low-intensity direct current to cortical areas, thereby facilitating or inhibiting neural activity in a polarity specific manner. Due to its low cost and safety, tDCS has been employed in a wide variety of studies, but much remains unknown regarding its mechanism of action in humans. Experiments carried out in animal and tissue models indicate that tDCS modulates synaptic plasticity mechanisms of long term potentiation and depression (LTP/D), however, these findings have never been translated to human subjects, limiting the practical utility of the research. Recently developed electroencephalographic (EEG) based measures now allow the interrogation of synaptic plasticity non-invasively in humans, making it possible to explore the effects of tDCS on human brain plasticity.

Conditions

Healthy; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Change in Amplitude of N100 Component of the Auditory Evoked Potential

  The amplitude of the N100 component will be averaged across individuals in each group. Grand averages from the two groups will be compared. Outcome is reported as the change from baseline to post-treatment (approximately 1 hour).

  approximately 1 hour

Study Arms (2)

Anodal Stimulation

EXPERIMENTAL

Device: tDCS

Sham Stimulation

SHAM COMPARATOR

Device: tDCS

Interventions

tDCS DEVICE

Transcranial electrical stimulator

Anodal Stimulation; Sham Stimulation

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18-50
• No psychiatric medication prescription
• No clinically significant head injury or neurological disease
• No dependence in the past 6 month or no substance abuse in the past month
• Sufficient spoken english to understand testing procedures
• Ability to give informed consent

You may not qualify if:

• History of transcranial electrical stimulation (tES) or other cortical energy exposure in the past 12 months; including
• participation in any neuromodulation studies
• History of seizures or epilepsy
• History of metallic cranial plates, screws, or implanted device
• History of craniotomy
• History of eczema on the scalp
• History of traumatic brain injury
• History of mental illness (Healthy group)
• Diagnosis of bipolar disorder
• Diagnosis of major depression
• Unable to give informed consent
• Hairstyle that is braided in cornrows or in dreadlocks

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Kelvin O. Lim

Minneapolis, Minnesota, 55414, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Elias Boroda
• Organization: University of Minnesota

borod002@umn.edu

763-498-4176

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: April 14, 2017
• Study Start: December 1, 2017
• Primary Completion: October 5, 2018
• Study Completion: October 5, 2018
• Last Updated: February 10, 2020
• Results First Posted: February 10, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)