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Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis

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ClinicalTrials.gov Identifier: NCT02085421
Recruitment Status : Not yet recruiting
First Posted : March 12, 2014
Last Update Posted : September 14, 2017
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Brief Summary:
The proposed pilot study is a randomized controlled study to assess effectiveness of transcranial direct current stimulation (tDCS) to enhance cognitive remediation therapy in patients with psychotic disorders. tDCS. Patients will be randomized into two arms: active tDCS vs. sham tDCS. The active tDCS will be applied at a current of 1-2 mA (milliamperes) via two saline soaked electrode sponges (3 cm x 4.5 cm) applied to the side of the head. The investigators hypothesis is that the use of tDCS will enhance the improvement seen with cognitive remediation therapy.

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

Detailed Description:

The proposed pilot study is a randomized controlled study to assess effectiveness of tDCS to enhance cognitive remediation therapy in patients with psychotic disorders. All patients will participate in cognitive remediation therapy (CRT). After initial consent form has been signed, all participants will undergo Matrics Consensus Cognitive Battery (MCCB) testing, Wechsler IQ (Intelligence Quotient) testing, and UPSA evaluation. Participants will then complete 3 CRT sessions per week, each lasting one hour, for a total of 12 weeks. The CRT will use a commercially available CRT software system such as Cogpack marker software as used by Haut et al, Lumosity or the PositScience software package. Each CRT session involves an in-session assessment of skill acquisition, as collected by commercially available CRT software. At the completion of each hour long CRT session, participants will also complete an n-back assessment. N-back testing will be run using software package E Prime (Psychology Software Tools).

Patients will be randomized into two arms: active tDCS vs. sham tDCS. The tDCS will be applied at a current of 1-2mA via two saline soaked electrode sponges (3 cm x 4.5 cm) each CRT session. The anode will be placed over left DLPFC (dorsolateral prefrontal cortex) at F3, according to the 10-20 international system for EEG electrode placement. The cathode will be placed over the contralateral supraorbital area. This placement is consistent with previous protocols targeting working memory. Both active and sham conditions will have identical electrode placement.

After electrodes have been placed, the participants will be instructed to log into CRT software using a unique patient identifier. Once logged in to CRT software they will be instructed to begin the session.

The tDCS will be applied at a current of 1-2mA via two saline soaked electrode sponges (3 cm x 4.5 cm) for the first 15 minutes of each CRT session in the active condition. In the sham condition, tDCS will be ramped up to 1-2 mA via two saline soaked electrode sponges (3 cm x 4.5 cm) over the first 30 seconds of each CRT session and then turned off.

Participants will complete the hour long CRT session. The software program instruct patient when the end of the session has been reached. At the end of each CRT session, the patient will then be instructed to complete an N-back assessment, run by E Prime software.

At the completion of the 12 weeks of CRT and active vs sham tDCS patients will repeat the UPSA and MCCB. Patients will also be asked to return for MCCB and UPSA testing at 3, 6 and 12 month follow up.

The time commitment of each generally CRT + n-back testing session will be approximately 90 minute. Additionally MCCB and UPSA testing will comprise a total of 6.5 hours. IQ testing will comprise approximately 1 hour of testing time. The total time commitment will consist of approximately 61.5 hours.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Active tDCS
The active tDCS will be applied at a current of 1-2mA via two saline soaked electrode sponges (3 cm x 4.5 cm) for the first 15 minutes of each CRT session in the active condition.
Device: tDCS
Transcranial direct current stimulation (tDCS) is a form of non-invasive neuromodulation that has been shown to enhance learning. tDCS is applied with current intensity of 1-2 mA of direct current and can be applied both before and during each cognitive remediation treatment session. Two saline soaked electrode sponges will be applied to the scalp.
Other Name: transcranial direct current stimulation

Sham Comparator: Sham tDCS
In the sham condition, tDCS will be ramped up to 1-2 mA via two saline soaked electrode sponges (3 cm x 4.5 cm) over the first 30 seconds of each CRT session and then turned off.
Device: tDCS
Transcranial direct current stimulation (tDCS) is a form of non-invasive neuromodulation that has been shown to enhance learning. tDCS is applied with current intensity of 1-2 mA of direct current and can be applied both before and during each cognitive remediation treatment session. Two saline soaked electrode sponges will be applied to the scalp.
Other Name: transcranial direct current stimulation




Primary Outcome Measures :
  1. Change in MATRICS Consensus Cognitive Battery from Baseline to 12 weeks [ Time Frame: Baseline, 12 weeks ]
    The MATRICS Consensus Cognitive Battery (MCCB) is a standardized battery for use with adults with schizophrenia and related disorders. Advancements in the past decade suggest that there may be opportunities for developing effective medications for improving cognition in people with schizophrenia. The MCCB was developed to help researchers and clinicians measure cognition in individuals who have been diagnosed with schizophrenia and related disorders, and contribute to the development of these types of medications. It is the only measure of cognitive performance that was developed under a national institute of mental health (NIMH) contract with participation from the U.S. Food and Drug Administration. Therefore, it is recommended for all clinical trials of cognition-enhancing drugs for schizophrenia.

  2. Change in University of California San Diego Performance Skills Assessment (UPSA) from Baseline to 12 weeks [ Time Frame: Baseline, 12 weeks ]
    This is a performance-based functional capacity measure.

  3. Change in N-Back from Baseline to 12 weeks [ Time Frame: Baseline, 12 weeks ]
    N-back testing is a performance task used to assess working memory. N-back testing will be run using software package E Prime (Psychology Software Tools).



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Meet diagnostic criteria for psychotic disorder (: psychosis not otherwise specified, substance induced psychosis, schizophreniform disorder, schizophrenia, schizoaffective disorder (depressed type or bipolar type) and Bipolar Affective Disorder with psychosis)
  2. Are age 18-64
  3. English speaking

Exclusion Criteria:

  1. History of seizures or epilepsy
  2. Metallic cranial plates, screws, or implanted devices
  3. History of craniotomy
  4. History of stroke
  5. History of eczema on scalp
  6. Pre-existing sores or lesions at sites of tDCS electrode placement
  7. Non removable facial piercings
  8. Current or possibility of current pregnancy

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): NCT02085421


Contacts
Contact: Kelvin O Lim, MD (612) 626-6772 kolim@umn.edu
Contact: Suzanne G Jasberg, MD (612) 273-9820 geie0014@umn.edu

Locations
United States, Minnesota
University of Minnesota Not yet recruiting
Minneapolis, Minnesota, United States, 55454
Contact: Kelvin O Lim, MD    612-626-6772    kolim@umn.edu   
Contact: Suzanne G Jasberg, MD    (612) 273-9820    geie0014@umn.edu   
Principal Investigator: Kelvin O Lim, MD         
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Kelvin O Lim, MD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT02085421     History of Changes
Other Study ID Numbers: LNPI-256
First Posted: March 12, 2014    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017

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

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
tdcs, neuromodulation, CRT, psychosis, schizophrenia

Additional relevant MeSH terms:
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders