Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis



Status:Not yet recruiting
Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 64
Updated:9/15/2017
Start Date:January 2018
End Date:July 2019
Contact:Kelvin O Lim, MD
Email:kolim@umn.edu
Phone:(612) 626-6772

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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.

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.

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
We found this trial at
1
site
Minneapolis, Minnesota 55455
(612) 625-5000
Principal Investigator: Kelvin O Lim, MD
Phone: 612-626-6772
Univ of Minnesota With a flagship campus in the heart of the Twin Cities, and...
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