Protocol Number: 08-M-0211

Title:

Safety of Transcranial Direct Current Brain Stimulation (TDCS) for Improvement of Psychotic Symptoms and Cognitive Functioning in Childhood Onset Schizophrenia (COS)

Number:

08-M-0211

Summary:

This study will test whether transcranial direct current stimulation (TDCS) can be used safely in children with schizophrenia and if it can improve memory and attention span or auditory hallucinations in these children, at least temporarily. TDCS has temporarily improved memory and attention span in healthy adults and a similar method called TMS has relieved auditory hallucinations in adults with schizophrenia. For the TDCS procedure, the child sits in a chair and two soft sponge electrodes are placed on the child's forehead and held in place with a soft wrapping. One sponge electrode is placed on an arm. The electrodes are attached to a stimulator with a wire.

Children with schizophrenia who meet the following criteria may be eligible for this study:

- Are 10 yrs or older age.

- Are participating in NIH protocol 03-M-0035.

- Are on a stable medication regimen for at least 6 months.

- Have problems with memory and attention span or have auditory hallucinations.

Participants are randomly assigned to receive either real or sham TDCS on an inpatient or outpatient basis in 20-minute sessions daily, except weekends, for 10 days. For real TDCS, patients receive stimulation to the front of the brain. For sham stimulation, the children have electrodes placed on the forehead, but no actual stimulation is delivered. In addition to TDCS, patients have the following procedures:

- Checks of blood pressure, pulse and breathing rate before, during and right after each stimulation and again 8 hours later.

- Electrocardiogram (EKG) and electroencephalogram (EEG) before starting stimulation and after completing the 10 days of TDCS.

- Interviews and examinations to check for side effects of TDCS.

- Pen-and-paper or computer tests of learning, attention and memory.

- At the end of the 10 sessions, children who were in the sham TDCS group are offered the same number of sessions of active TDCS.

- Follow-up telephone call 1 month after the end of stimulation to see how the child is doing.

- 1- to 2-day outpatient visit 6 months after the stimulation. This visit includes interviews with the parent and the child, rating of the child's psychiatric symptoms, and pen-and-paper or computer tests of thinking, attention and memory.

Sponsoring Institute:

National Institute of Mental Health (NIMH)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility Criteria:

INCLUSION CRITERIA:

- COS patients (age 10 and older) recruited and followed under the current protocol 03-M-0035, where subjects have been stable on their medications for 6 months but continue to experience either:

a. Cognitive difficulties as evidenced by information from parents and teachers, clinical interview, and performance (below average based on published norms for each test) on neurocognitive tests (WMS-III, Letter-Number span; verbal and non verbal, attention/vigilance (CPT-IP), and verbal learning (HVLT-R) sub tests of the NIMH MATRICS battery).

b. Significant auditory hallucinations as measured by SAPS (scores above 2) or BPRS (scores above 3).

EXCLUSION CRITERIA:

In addition to the exclusion criteria under protocol 03-M-0035, the following will be exclusionary:

- Broken or abnormal skin in the area of the electrodes.

- Presence of metal in the cranial cavity.

- Holes in the skull from trauma or surgery.

- Positive pregnancy test.

- The presence of other psychiatric illness (e.g. severe anxiety, OCD etc) unless the patient has been on a stable psychotropic medication regimen for the past 6 months. Such a regimen would be characterized by no more than a 25% change in dosage of psychotropic medication(s) for at least 6 months prior to initiation of study.

- Presence of significant neurologic illness (e.g. brain tumors, epilepsy, metabolic disorders, etc) that requires ongoing treatment.

Special Instructions:

Currently Not Provided

Keywords:

Treatment Study

Psychosis

Electrical Stimulation

Refractory

Novel

Recruitment Keyword(s):

Childhood Onset Psychotic Disorders

Schizophrenia

Psychosis

Condition(s):

Childhood Onset Psychotic Disorders

Schizophrenia

Psychosis

Mental Disorders@@@Mental Disorder Diagnosed in Childhood @@@@@@

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Behavioral: Electrical Polarization

Supporting Site:

National Institute of Mental Health

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Asarnow JR, Ben-Meir S. Children with schizophrenia spectrum and depressive disorders: a comparative study of premorbid adjustment, onset pattern and severity of impairment. J Child Psychol Psychiatry. 1988 Jul;29(4):477-88.

Watkins JM, Asarnow RF, Tanguay PE. Symptom development in childhood onset schizophrenia. J Child Psychol Psychiatry. 1988 Nov;29(6):865-78.

Russell AT, Bott L, Sammons C. The phenomenology of schizophrenia occurring in childhood. J Am Acad Child Adolesc Psychiatry. 1989 May;28(3):399-407.

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