NCT00757497

Transcranial Direct Current Brain Stimulation to Treat Patients With Childhood-Onset Schizophrenia

Terminated Phase 1 Last updated 12 December 2019

What this trial tests

Phase 1 trial testing Electrical Polarization in Childhood Onset Psychotic Disorders in 20 participants. Terminated before completion.

Timeline

17 September 2008

18 August 2015

Quick facts

Lead sponsor	National Institute of Mental Health (NIMH)
Phase	Phase 1
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Primary purpose	treatment
Enrollment	20
Start date	17 September 2008
Estimated completion	18 August 2015
Sites	1 location across United States

Drugs / interventions tested

• Electrical Polarization

Conditions studied

• Childhood Onset Psychotic Disorders — all drugs for Childhood Onset Psychotic Disorders →
• Schizophrenia — all drugs for Schizophrenia →
• Psychosis — all drugs for Psychosis →
• Mental Disorders — all drugs for Mental Disorders →

Sponsor

National Institute of Mental Health (NIMH)

Who can join

10 and older, any sex, with Childhood Onset Psychotic Disorders or Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Disrupted sensorimotor and social-cognitive networks underlie symptoms in childhood-onset schizophrenia.
   Berman RA, Gotts SJ, McAdams HM, Greenstein D, et al · · 2016 · cited 87× · PMID 26493637 · DOI 10.1093/brain/awv306
2. Transcranial magnetic stimulation (TMS) for schizophrenia.
   Dougall N, Maayan N, Soares-Weiser K, McDermott LM, et al · · 2015 · cited 37× · PMID 26289586 · DOI 10.1002/14651858.cd006081.pub2