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Modulating Human Cortical Plasticity With Transcranial Electrical Stimulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03114488
Recruitment Status : Completed
First Posted : April 14, 2017
Results First Posted : February 10, 2020
Last Update Posted : February 10, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Healthy Schizophrenia Device: tDCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Modulating Human Cortical Plasticity With Transcranial Electrical Stimulation
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : October 5, 2018
Actual Study Completion Date : October 5, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: Anodal Stimulation Device: tDCS
Transcranial electrical stimulator

Sham Comparator: Sham Stimulation Device: tDCS
Transcranial electrical stimulator




Primary Outcome Measures :
  1. Change in Amplitude of N100 Component of the Auditory Evoked Potential [ Time Frame: approximately 1 hour ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03114488


Locations
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United States, Minnesota
Kelvin O. Lim
Minneapolis, Minnesota, United States, 55414
Sponsors and Collaborators
University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03114488    
Other Study ID Numbers: 1703M09401
First Posted: April 14, 2017    Key Record Dates
Results First Posted: February 10, 2020
Last Update Posted: February 10, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders