Transcranial Direct Current Stimulation and Cognitive Remediation Therapy for Psychosis
Condition: Psychosis
MeSH terms: Psychotic Disorders; Mental Disorders
Study type: Interventional

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.
    

Intervention name(s): tDCS
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): transcranial direct current stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: tdcs, neuromodulation, CRT, psychosis, schizophrenia