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Maximizing the Impact of Neuroplasticity Using Transcranial Electrical Stimulation Study 1 (MINUTES)

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ClinicalTrials.gov Identifier: NCT03896425
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:

Non-invasive neuromodulation, such as transcranial direct current stimulation ( tDCS) , is emerging as an important therapeutic tool with documented effects on brain circuitry, yet little is understood about h ow it changes cognition. In particular, tDCS may have a critical role to play in generalization, that is how training in one domain generalizes to unlearned or unpracticed domains. This problem has resonance for disorders with cognitive deficits, such as schizophrenia.

Understanding how tDCS affects brain circuity is critical to the design and application of effective interventions, especially if the effects are different for healthy vs. psychiatric populations. In previous research, one clue to the mechanism underlying increased learning and generalization with tDCS was provided by neuroimaging data from subjects with schizophrenia undergoing cognitive training where increases in thalamocortical (prefrontal) functional connectivity (FC) predicted greater generalization.

The premise of this proposal is that increases in thalamocortical FC are associated with the generalization of cognitive training, and tDCS facilitates these increases. The overarching goals of this proposal are to deploy neuroimaging and cognitive testing to understand how tDCS with cognitive training affect thalamocortical circuitry in individuals with and without psychosis and to examine variability in response within both groups.

Study 1 will compare right prefrontal, left prefrontal and sham tDCS during concurrent cognitive training over 12 weeks in 90 healthy controls. Study 2 will be similar in all aspects but will examine 90 patients with schizophrenia or schizoaffective disorder and include clinical assessments. Results of the study will provide crucial information about location of stimulation, length of treatment, modeled dosage, trajectory and durability needed to guide future research and interventions for cognitive impairments.


Condition or disease Intervention/treatment Phase
Transcranial Direct Current Stimulation Healthy Device: Transcranial direct current stimulation (tDCS) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Increased Thalamocortical Connectivity in Tdcs-potentiated Generalization of Cognitive Training
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : April 2024
Estimated Study Completion Date : April 2024

Arm Intervention/treatment
Experimental: right active-tDCS
2-3 times/week for 12 weeks: ramp-up for 30 seconds, 2mA right (AF4 anode - AF3 cathode) for 20 min, and then ramp-down for 30 seconds.
Device: Transcranial direct current stimulation (tDCS)
Three different stimulation montages will be programmed: right, left and sham. During the Ramp periods, 2 mA current will be delivered to both AF3 and AF4 with an ascending (RampUp) and descending ramp (RampDown) over 30 sec via two saline soaked electrode sponges (~ 25cm²; current density = 0.08 mA/cm²). In this way, all subjects experience the same sensation on both sides to blind them to condition. During the Constant period, current will be set based on the Condition: Right - 2mA AF4 anode-AF3 cathode; Left - 2mA applied to AF3 anode-AF4 cathode; Sham - current turned off.

Experimental: left active-tDCS
2-3 times/week for 12 weeks: ramp-up for 30 seconds, 2mA left (AF3 anode - AF4 cathode) for 20 min, and then ramp-down for 30 seconds.
Device: Transcranial direct current stimulation (tDCS)
Three different stimulation montages will be programmed: right, left and sham. During the Ramp periods, 2 mA current will be delivered to both AF3 and AF4 with an ascending (RampUp) and descending ramp (RampDown) over 30 sec via two saline soaked electrode sponges (~ 25cm²; current density = 0.08 mA/cm²). In this way, all subjects experience the same sensation on both sides to blind them to condition. During the Constant period, current will be set based on the Condition: Right - 2mA AF4 anode-AF3 cathode; Left - 2mA applied to AF3 anode-AF4 cathode; Sham - current turned off.

Sham Comparator: sham tDCS
Current will be turned off immediately after the initial 30-second ramp-up period.
Device: Transcranial direct current stimulation (tDCS)
Three different stimulation montages will be programmed: right, left and sham. During the Ramp periods, 2 mA current will be delivered to both AF3 and AF4 with an ascending (RampUp) and descending ramp (RampDown) over 30 sec via two saline soaked electrode sponges (~ 25cm²; current density = 0.08 mA/cm²). In this way, all subjects experience the same sensation on both sides to blind them to condition. During the Constant period, current will be set based on the Condition: Right - 2mA AF4 anode-AF3 cathode; Left - 2mA applied to AF3 anode-AF4 cathode; Sham - current turned off.




Primary Outcome Measures :
  1. Changes in thalamocortical functional connectivity (FC) [ Time Frame: baseline; mid-test (week 6); post-test (week 12) ]
    Participants will complete MRI sessions on a 3T scanner located in the Center for Magnetic Resonance Research (CMRR) at the University of Minnesota. To calculate FC, we will characterize the global and local network connectivity using a graph theory analysis. This will be formed by extracting the fMRI time courses from ninety regions of interest, based on ROIs defined by the freesurfer T1 parcellation. We will focus on low frequency (0.06-0.125 Hz) oscillations in the BOLD signal. We will estimate the functional connectivity by computing the absolute value of the Pearson's correlation between all possible pairs of time series, creating a 90 x 90 (N x N) connectivity matrix. The network topology metrics, characteristic path length and clustering coefficient, will be computed from the connectivity matrix, averaged over a threshold range representing .1 to .3 of the maximum possible number of edges in the graph. We will also measure global strength and diversity of the nodes.

  2. Change in Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) composite score [ Time Frame: baseline; follow up (week 24). ]
    Intends to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. The composite score is calculated as a sum of all T scores from the battery's sub tests. Composite scores range from 213 (0.1 %tile) to 487 (99.9 %tile)

  3. Change in N-back score [ Time Frame: baseline; mid-test (week 6); post-test (week 12); ]
    The n-back measures working memory capacity. The participant is presented with a series of stimuli and instructed to indicate with a button press when the current stimulus matches the stimulus that appeared a pre-determined number (n) of trials before. Both accuracy (percentage of correct responses) and reaction time (milliseconds) will be recorded, and d' (d prime) will be calculated as a measure of signal detection. Increase in d' signifies improved signal detection, i.e. a better outcome.



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Ability to provide consent and comply with study procedures.
  2. Age 18 - 60 years old.
  3. Estimated IQ range within the range: 70 ≤ IQ ≤ 107.5.
  4. No current psychiatric or addictive disorder diagnosis as measured by the MINI (Mini International Neuropsychiatric Interview).
  5. Ability to participate in three weekly 45' training sessions over 12 weeks and participate in four assessments.

Exclusion Criteria:

  1. Any medical condition or treatment with neurological sequelae (e.g. stroke, tumor, loss of consciousness > 30 min, HIV).
  2. Contraindications for tDCS or MRI scanning (tDCS contraindication: history of seizures; MRI contraindications: metal implants, pacemakers, or any other implanted electrical device, injury with metal, braces, dental implants, non-removable body piercings, pregnancy, breathing or movement disorder). Items listed as MRI contraindications will be reviewed by a safety committee and may in some cases be approved as safe to scan.

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): NCT03896425


Contacts
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Contact: Lei Xuan 612-626-7302 xuanx015@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Kelvin Lim, MD    612-273-9803    kolim@umn.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute of Mental Health (NIMH)

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Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03896425     History of Changes
Other Study ID Numbers: STUDY00003506_01
1RF1MH116987-01 ( U.S. NIH Grant/Contract )
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
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
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
tDCS
cognitive training
functional connectivity
non-invasive brain stimulation