Transcranial Direct Current Stimulation (tDCS) for Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Schizophrenia+3 More
Transcranial Direct Current Stimulation (tDCS) - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial will use transcranial direct current stimulation (tDCS) to study how it changes cognition, with a focus on generalization (how training in one domain affects unlearned domains). The study will compare tDCS in healthy controls and patients with schizophrenia or schizoaffective disorder.

Eligible Conditions
  • Schizophrenia
  • Transcranial Direct Current Stimulation
  • Schizoaffective Disorder

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

6 Primary · 3 Secondary · Reporting Duration: baseline; mid-test (week 6); post-test (week 12); follow-up (week 24)

Week 12
Changes in thalamocortical functional connectivity (FC)
Week 12
Change in DPX performance
Change in N-back performance
Dual-Energy X-Ray Absorptiometry
Changes in task-dependent thalamocortical functional connectivity (fMRI) during the N-back task.
Week 24
Change in Brief Negative Symptom Scale (BNSS) score
Change in Brief Psychiatric Rating Scale (BPRS) score
Schizophrenia
Change in University of California San Diego Performance-Based Skills Assessment - Brief (UPSA-B)

Trial Safety

Safety Progress

1 of 3

Side Effects for

tDCS + Robotic Arm Therapy
3%back pain flair up
3%Myasthenia Gravis
This histogram enumerates side effects from a completed 2018 Phase 2 trial (NCT01726673) in the tDCS + Robotic Arm Therapy ARM group. Side effects include: back pain flair up with 3%, Myasthenia Gravis with 3%.

Trial Design

3 Treatment Groups

left active-tDCS
1 of 3
right active-tDCS
1 of 3
sham tDCS
1 of 3

Experimental Treatment

Non-Treatment Group

90 Total Participants · 3 Treatment Groups

Primary Treatment: Transcranial Direct Current Stimulation (tDCS) · Has Placebo Group · N/A

left active-tDCS
Device
Experimental Group · 1 Intervention: Transcranial Direct Current Stimulation (tDCS) · Intervention Types: Device
right active-tDCS
Device
Experimental Group · 1 Intervention: Transcranial Direct Current Stimulation (tDCS) · Intervention Types: Device
sham tDCS
Device
ShamComparator Group · 1 Intervention: Transcranial Direct Current Stimulation (tDCS) · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Direct Current Stimulation (tDCS)
2016
Completed Phase 2
~380

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline; mid-test (week 6); post-test (week 12); follow-up (week 24)

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,528 Previous Clinical Trials
1,816,541 Total Patients Enrolled
227 Trials studying Schizophrenia
86,764 Patients Enrolled for Schizophrenia
University of MinnesotaLead Sponsor
1,243 Previous Clinical Trials
1,481,413 Total Patients Enrolled
15 Trials studying Schizophrenia
985 Patients Enrolled for Schizophrenia

Eligibility Criteria

Age 18 - 65 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have an IQ within the range 70 to 115.
You are not currently suffering from a current addictive disorder or a sleep disorder.
You are medically stable and on stable medications for at least one month before start of study.
You are able to participate in three weekly 45' training sessions over 12 weeks and participate in four assessments.
You have schizophrenia or schizoaffective disorder.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 26th, 2021

Last Reviewed: November 7th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.