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Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis

Primary Purpose

Psychosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
tDCS
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychosis focused on measuring tdcs, neuromodulation, CRT, psychosis, schizophrenia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Meet diagnostic criteria for schizophrenia or schizoaffective disorder
  2. Are age 18-64
  3. Fluent in written and spoken English
  4. Have an outpatient status of at least 1 month prior to participation
  5. Has been on a stable dose of psychiatric medication for at least one month prior to participation

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
  9. Has received a clinically meaningful dose of a targeted cognitive training intervention in the last 12 months

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active tDCS

Sham tDCS

Arm Description

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 20 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.

Outcomes

Primary Outcome Measures

Change in Brief Assessment of Cognition in Schizophrenia (BACS) from Baseline to Post-Training
Change in VRFCAT from Baseline to Post-Training
This is a performance-based functional capacity measure.
Change in N-Back from Baseline to Post-Training
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).

Secondary Outcome Measures

Full Information

First Posted
March 6, 2014
Last Updated
February 12, 2023
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT02085421
Brief Title
Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis
Official Title
Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 14, 2019 (Actual)
Primary Completion Date
February 9, 2023 (Actual)
Study Completion Date
February 9, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.
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 various neurocognitive and psychological assessments including the Brief Assessment of Cognition in Schizophrenia (BACS), an EEG, and several other tasks/assessments. Participants will then complete 2-4 CRT sessions per week, each lasting approximately one hour, for a total of 10 sessions. The CRT will use a commercially available PositScience software package. Each CRT session involves an in-session assessment of skill acquisition, as collected by commercially available CRT software. 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 (Fp2). 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 20 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 instructs the patient when the end of the session has been reached. At the completion of the 10 sessions of CRT, both active and sham tDCS patients will repeat the the same assessments from the beginning, including the BACS, another EEG, and several other tasks/assessments. Patients will also be asked to return for a 1-month follow-up where most of the same tasks/assessments are completed. The consent and baseline assessments take about 8 hours in total and can be split up into 2-4 appointments. Each of the 10 training sessions lasts approximately 1 hour for a total of 10 hours of training. The post-training assessments take about 6 hours and can be split up into 2-3 appointments. The 1-month follow-up takes approxmately 3.5 hours and can be completed in 1-2 appointments. The total time commitment for this study is approximately 28-32 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis
Keywords
tdcs, neuromodulation, CRT, psychosis, schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active tDCS
Arm Type
Active Comparator
Arm Description
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 20 minutes of each CRT session in the active condition.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
tDCS
Other Intervention Name(s)
transcranial direct current stimulation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Brief Assessment of Cognition in Schizophrenia (BACS) from Baseline to Post-Training
Time Frame
Baseline, 3-5 weeks
Title
Change in VRFCAT from Baseline to Post-Training
Description
This is a performance-based functional capacity measure.
Time Frame
Baseline, 3-5 weeks
Title
Change in N-Back from Baseline to Post-Training
Description
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).
Time Frame
Baseline, 3-5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Meet diagnostic criteria for schizophrenia or schizoaffective disorder Are age 18-64 Fluent in written and spoken English Have an outpatient status of at least 1 month prior to participation Has been on a stable dose of psychiatric medication for at least one month prior to participation Exclusion Criteria: History of seizures or epilepsy Metallic cranial plates, screws, or implanted devices History of craniotomy History of stroke History of eczema on scalp Pre-existing sores or lesions at sites of tDCS electrode placement Non removable facial piercings Current or possibility of current pregnancy Has received a clinically meaningful dose of a targeted cognitive training intervention in the last 12 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian S Ramsay, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States

12. IPD Sharing Statement

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Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis

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