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Electrical Stimulation

Transcranial Electrical Stimulation for Schizophrenia (MINUTES Trial)

N/A

Waitlist Available

Research Sponsored by University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 - 60 years old.

Schizophrenia or schizoaffective disorder as assessed by the MINI (Mini International Neuropsychiatric Interview)(Sheehan et al., 1998).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline; mid-test (week 6); post-test (week 12); follow-up (week 24)

Awards & highlights

MINUTES Trial 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.

Who is the study for?

This trial is for individuals aged 18-60 with schizophrenia or schizoaffective disorder, who are stable on medications and can commit to a 12-week training program. They must have an IQ within the range of 70-115, no addictive or sleep disorders, and be able to consent to study procedures. People with medical conditions affecting the brain or those unable to undergo tDCS or MRI scans cannot participate.Check my eligibility

What is being tested?

The study tests how transcranial direct current stimulation (tDCS) affects cognitive function in people with and without psychosis. It involves neuroimaging and cognitive testing during tDCS sessions alongside cognitive training over a period of 12 weeks, aiming to understand its impact on brain connectivity.See study design

What are the potential side effects?

Potential side effects of tDCS may include mild itching, tingling, discomfort at the electrode site, headache, fatigue, nausea or insomnia. Serious side effects are rare but could involve seizures if there's a pre-existing condition.

MINUTES Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 60 years old.

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I have been diagnosed with schizophrenia or schizoaffective disorder.

MINUTES Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline; mid-test (week 6); post-test (week 12); follow-up (week 24)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline; mid-test (week 6); post-test (week 12); follow-up (week 24)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline; mid-test (week 6); post-test (week 12); follow-up (week 24) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in DPX performance

Schizophrenia

Change in N-back performance

+3 more

Secondary outcome measures

Change in Brief Negative Symptom Scale (BNSS) score

Change in Brief Psychiatric Rating Scale (BPRS) score

Change in University of California San Diego Performance-Based Skills Assessment - Brief (UPSA-B)

Side effects data

From 2018 Phase 2 trial • 54 Patients • NCT01726673

back pain flair up

Myasthenia Gravis

100%

80%

60%

40%

20%

Study treatment Arm

tDCS + Robotic Arm Therapy

tDCS Sham + Robotic Arm Therapy

MINUTES Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: right active-tDCSExperimental Treatment1 Intervention

2-3 times/week for 12 weeks: ramp-up for 30 seconds, 2mA right (AF4 anode - AF3 cathode) for 20 min, and then ramp-down for 30 seconds.

Group II: left active-tDCSExperimental Treatment1 Intervention

2-3 times/week for 12 weeks: ramp-up for 30 seconds, 2mA left (AF3 anode - AF4 cathode) for 20 min, and then ramp-down for 30 seconds.

Group III: sham tDCSPlacebo Group1 Intervention

Current will be turned off immediately after the initial 30-second ramp-up period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Direct Current Stimulation (tDCS)

2016

Completed Phase 2

~2100

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of MinnesotaLead Sponsor

1,379 Previous Clinical Trials

1,588,438 Total Patients Enrolled

National Institute of Mental Health (NIMH)NIH

2,783 Previous Clinical Trials

2,689,042 Total Patients Enrolled

Media Library

Transcranial Direct Current Stimulation (tDCS) (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03896438 — N/A

Schizoaffective Disorder Research Study Groups: left active-tDCS, right active-tDCS, sham tDCS

Schizoaffective Disorder Clinical Trial 2023: Transcranial Direct Current Stimulation (tDCS) Highlights & Side Effects. Trial Name: NCT03896438 — N/A

Transcranial Direct Current Stimulation (tDCS) (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03896438 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are presently participating in this research trial?

"Affirmative, according to information available on clinicaltrials.gov this clinical trial is currently seeking participants who meet the criteria. It was initially posted on July 1st 2019 and updated most recently on October 28th 2022. The research requires 90 people to be enrolled at a single site."

Answered by AI

Does this experimental research include elderly participants?

"As outlined in the eligibility criteria, participants must be between 18 and 60 years old to take part in this medical trial."

Answered by AI

Are there any available slots in this research endeavor for participants?

"Affirmative. As shown on clinicaltrials.gov, this medical study began recruiting patients after its inception in July 2019 and is still ongoing today as of October 2022. This trial seeks to enroll 90 individuals from a single site."

Answered by AI

Is there an option for me to become a participant in this experiment?

"This trial is looking to enrol 90 individuals with schizophrenia aged between 18 and 60. To be eligible, patients must provide consent, have an IQ of 70-115, not suffer from addiction or sleep disorders, maintain clinical stability for one month prior to the start of the study and participate in three weekly 45 minute sessions over 12 weeks as well as four assessments."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Maximizing the Impact of Neuroplasticity Using Transcranial Electrical Stimulation Study 2

2019. "Maximizing the Impact of Neuroplasticity Using Transcranial Electrical Stimulation Study 2". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03896438.