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HealthyNCT03114488

Modulating Human Cortical Plasticity With Transcranial Electrical Stimulation

A study testing tDCS in people with Healthy and Schizophrenia, run by University of Minnesota at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Healthy, Schizophrenia
What is being tested?
tDCS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
41 participants
Where
1 siteUnited States
Study dates
1 Dec 2017to 5 Oct 2018
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Kelvin O. Lim

    Minneapolis, Minnesota, 55414

Other trials in United States

About this study

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.

Read the detailed description

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 thought play a causal role in the pathophysiology of several psychiatric disorders, including schizophrenia (SZ). Treatments that can probe or even enhance plasticity have potential to be of great clinical 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. Its positive effects in a wide range of neurological conditions, as well as its tolerability and low cost, have catalyzed the use of tDCS as a clinical tool. However, issues regarding efficacy and variability of outcomes continue to limit the clinical potential of this promising intervention. Investigation of the physiological mechanisms that subserve tDCS effects in humans is needed to inform treatment protocols and enhance efficacy.

Studies in tissue models have revealed that direct current application alters membrane polarization and modulates long-term potentiation and depression (LTP/D), key mechanisms of synaptic plasticity. In Vivo application of tDCS has been shown to modulate LTP and learning in the rat hippocampus and motor cortex. This modulation was shown to be, persistent, input-specific, and N-methyl-D-aspartate receptor (NMDAR) dependent. These works demonstrate the utility of tDCS in modifying plasticity and learning. Given the limitations placed on invasive procedures, investigating the effects of tDCS on plasticity in the human brain has proved to be much more challenging, limiting the translation and thus the practical utility of the basic research. Utilizing modern, non-invasive methods to probe plasticity in humans has the potential to bridge this translational gap.

Recently developed techniques utilizing electroencephalography (EEG) now enable the non-invasive interrogation of plasticity in the human cortex. Clapp et al., (2005) demonstrated the feasibility of inducing LTP in the cortex by rapid presentation of visual or auditory stimuli, observable as changes in sensory evoked potentials recorded from the scalp. This paradigm, termed stimulus specific plasticity (SSP), is a direct parallel to the high frequency electrical stimulation protocols used to elicit LTP in tissue preparations and satisfies the cardinal features of Hebbian plasticity. Thus sensory-induced plasticity is a useful measure of cortical plasticity that is readily translatable from animals to humans. Further, several studies have used SSP to reveal plasticity deficits in SZ and bipolar disorder, demonstrating the clinical relevance of this assay. In addition, because SSP is a functionally relevant manifestation of LTP, it enables assessment of the efficacy of interventions that target plasticity mechanisms, making it the perfect tool to use for evaluating tDCS effects.

The premise of this proposal is based on prior findings demonstrating the modulatory effect of tDCS on synaptic plasticity in animal and tissue models. Due to methodological limitations, very little work has been done to translate these findings to humans. Because the direct effects of tDCS on plasticity in the humans remains uninvestigated, the overarching goal of this proposal is to assess the in vivo efficacy of tDCS in modulating synaptic plasticity in the auditory cortex of the human brain. To this end, the researchers will conduct a study featuring simultaneous tDCS and EEG recording in a both healthy participants and SZ patients. The two separate cohorts will be randomized into either three or two treatment arms (cathodal, anodal, sham - healthy participants / Anodal and Sham - SZ patients). All subjects will undergo EEG recording during presentation of auditory tones to establish baseline auditory evoked potentials (AEP). LTP will be induced by a high frequency presentation (sensory tetanus) of that same tone for 5 min. Stimulation will begin 10 min prior to the LTP induction and will stop at the end the 5 min period. Post-tetanus EEG recordings of AEP's will be compared to baseline AEP's to analyze the impact of tDCS on neural plasticity.

Specific Aim 1: Evaluate the effects of Anodal tDCS vs. Cathodal tDCS vs. Sham on induction of LTP in a healthy population: Significant findings demonstrate that anodal tDCS impacts neuronal function by enhancing LTP induction. Based on these findings in animal and tissue models, it is expected that anodal tDCS will lead to a greater facilitation of LTP than cathodal or sham stimulation Specific Aim 2: Evaluate the efficacy of Anodal tDCS in enhancing induction of LTP in a population of SZ Patients: SZ patients show deficient capacity to support LTP in the auditory cortex. Effect of tDCS are putatively emergent from modulation of NMDAR dependent plasticity mechanisms. Using the SSP paradigm the study will evaluate the efficacy of tDCS in modulating LTP measures. Based on mechanistic work in animals demonstrating the NMDAR dependent action of tDCS, it is expected that anodal tDCS will enhance the induction of LTP compared to sham.

Being tested
tDCS
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • tDCSDevice

    Transcranial electrical stimulator

Study groups in NCT03114488
Study groupRoleWhat they receive
Anodal StimulationExperimentalNot described
Receives: Device: tDCS
Sham StimulationSham comparatorNot described
Receives: Device: tDCS

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: approximately 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2017
  2. Study start1 Dec 2017
  3. Primary completion5 Oct 2018
  4. Study completion5 Oct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03114488
Sponsor's protocol ID
1703M09401
Status last verified
Jan 2020
First submitted
22 Mar 2017
Last updated
10 Feb 2020
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing tDCS in people with Healthy and Schizophrenia, run by University of Minnesota at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Amplitude of N100 Component of the Auditory Evoked Potential (time frame: approximately 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2020.

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Clinical Trial NCT03114488 | AzTrials