TRANSCRANIAL DIRECT CURRENT STIMULATION FOR THE TREATMENT OF POSITIVE AND COGNITIVE SYMPTOMS IN SCHIZOPHRENIA

Study ID
STU 042012-024

Cancer Related
No

Healthy Volunteers
No

Study Sites

  • UT Southwestern-Other
  • UT Southwestern University Hospital– Zale Lipshy

Contact
Debra Bushong
214-648-4653
debra.bushong@utsouthwestern.edu

Principal Investigator
Carol Tamminga

Summary

This study aims to test the efficacy of combined pharmacological and non-invasive non-pharmacological (tDCS) treatment of psychotic and cognitive symptoms in SZ and related psychotic disorders, including SZP with acute psychotic symptoms and SZP with residual psychotic symptoms, carried out in the framework of the biology-driven model of the MTL/ hippocampal metaplasticity. The study is designed as a randomized double-blind sham-controlled clinical trial including two groups of SZP [(1) SZP with acute psychotic symptoms, [Quote]acute psychosis study[Quote] (2) SZP with residual psychotic symptoms, [Quote]residual psychosis study[Quote]], each randomized into two parallel treatment arms: (1) routine pharmacological treatment + tDCS or (2) routine pharmacological treatment + Sham.

We anticipate to consent and screen approximately 100 SZP (including screen failures and early withdrawals), in order to have 80 volunteers to enter the treatment protocol.

an [Quote]acute psychosis study[Quote] will include SZP (n[?]30) who have (1) recent exacerbation of psychotic symptoms within the past 3 - 6 months; (2) baseline Positive and negative Symptoms of Schizophrenia (PanSS) Positive Symptoms subscale score of 20 or higher; (3) baseline score of 4 or higher on PanSS items P1 (Delusions) and/or P3 (Hallucinatory Behavior). SZP within the [Quote]acute psychosis study[Quote] will be randomized to either active (routine pharmacological treatment + tDCS) or sham (routine pharmacological treatment + Sham) treatment, n[?]15 in each treatment arm.

a [Quote]residual psychosis study[Quote] will include SZP (n[?]50) who have (1) stable psychotic symptoms within the past 3 - 6 months (no recent psychosis exacerbation); (2) baseline PanSS Positive Symptoms subscale score of 19 or lower; (3) baseline score of 3 or lower on PanSS items P1 (Delusions) and/or P3 (Hallucinatory Behavior). SZP within the [Quote]residual psychosis study[Quote] will be randomized to either active (routine pharmacological treatment + tDCS) or sham (routine pharmacological treatment + Sham) treatment, n[?]25 in each treatment arm.

The routine pharmacological treatment will include aDP, and, if indicated, other psychotropic medications, and will be administered and monitored by the volunteers' psychiatric providers. This study will not require any medication changes, and will not introduce any additional aDP or other psychotropic medications, but will enroll SZ volunteers on routine pharmacological treatments [Quote]as usual[Quote].

tDCS will be administered as an adjunct treatment to the volunteers' pharmacological regiments. The anode electrode will be placed over left DLPFC and the cathode electrode will be located over the left TPC. according to standards of tDCS use in SZ and other psychiatric and neurological conditions (McGuire et al., 1993; Dierks et al., 1999; Sommer et al., 2008; Brunelin et al., in Press), stimulation parameters will be 2.0 ma, 20 minutes per session. tDCS will be administered twice daily with inter-treatment interval of at least 3 hours, for 5 consecutive days, for a total of 10 tDCS treatment sessions. Sham stimulation will mimic active tDCS treatments, including a display of the chosen stimulation mode, except that no effective stimulation will be administered. after 40m seconds of real stimulation (2.0 ma), only a small current pulse will occur every 550 ms (110 [MiCRo-SYMBoL]a over 15 ms) during the 20 minutes session. This current pulse will enable an impedance control which reliably detects insufficient electrode contact or electrode disconnection. average current over time will not exceed 2 [MiCRo-SYMBoL]a which has no therapeutic effect.

all patients, research raters, and clinical providers will be blind to randomization (tDCS vs. Sham). Comprehensive assessments including clinical symptom ratings, neuropsychological testing, and brain imaging (structural MRi, VaSo and fMRi BoLD coupled with a cognitive/associational memory paradigm) will be conducted at baseline and 2 days after completion the last tDCS session.

Participant Eligibility


* Must provide consent to participate after being fully informed about the study procedures and the information to be collected

* Males and females

* Ages 18-65 years old

* All races and ethnicities

* Must meet DSM-IV criteria for schizophrenia, schizoaffective disorder or bipolar I disorder with psychotic features

* Must be judged to be capable of completing the study procedures by study investigators.

* Must be able to read, speak, and understand English*