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NeuroRehabilitation + TES for Cognitive Disorders (PCN Trial)

N/A

Recruiting

Led By Benjamin M Hampstead, Ph.D.

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

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

Must have

Participants will be age 50 or older

Be older than 18 years old

Must not have

Sensory or motor impairments that limit the ability to take part in the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up pre, post, and follow-up at up to 1 year post treatment

Summary

This trial will test whether cognitive rehabilitation and transcranial electrical stimulation (TES) can improve cognitive abilities in people with difficulties due to aging, neurodegenerative diseases, or cardiovascular disease.

Who is the study for?

This trial is for individuals aged 50 or older who have noticed a decline in their cognitive abilities. It's open to those with and without diagnosed cognitive issues. People can't join if they have serious mental illnesses, are pregnant, might become pregnant, have metal/electronic implants in the head, history of substance abuse, or sensory/motor impairments that would limit participation.

What is being tested?

The study tests whether cognitive rehabilitation combined with transcranial electrical stimulation (TES) improves thinking skills like attention and memory. TES involves small electric currents applied to the brain. Participants will receive either active TES (tRNS/tDCS/tACS), sham TES (placebo), or cognitively based interventions.

What are the potential side effects?

Transcranial electrical stimulation may cause discomfort at the electrode site, headache, fatigue, nausea or itching under the electrodes during application. Cognitive interventions typically do not have physical side effects but could potentially lead to frustration or mental fatigue.

Eligibility Criteria

Inclusion Criteria

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

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I am 50 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any sensory or motor impairments that limit my participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ pre, post, and follow-up at up to 1 year post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~pre, post, and follow-up at up to 1 year post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre, post, and follow-up at up to 1 year post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

TES side effect questionnaire

Other study objectives

Blood oxygen level dependent (BOLD) changes as assessed by functional magnetic resonance imaging (fMRI)

Cognitive changes as assessed by neuropsychological testing

Magnetic resonance spectroscopy

+1 more

Trial Design

7Treatment groups

Experimental Treatment

Placebo Group

Group I: Sham TES + Cognitively based interventionExperimental Treatment4 Interventions

This condition combines sham TES and cognitively based interventions for some or all of the study sessions

Group II: Cognitively based interventionExperimental Treatment1 Intervention

Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation.

Group III: Active and Sham TESExperimental Treatment6 Interventions

Participants will receive active and sham TES

Group IV: Active TES, Sham TES, Cognitively based interventionsExperimental Treatment7 Interventions

This condition combines active and sham TES with cognitively based interventions using a cross-over design

Group V: Active TES + Cognitively based interventionExperimental Treatment4 Interventions

This condition combines active TES and cognitively based interventions for some or all of the study sessions

Group VI: Active TESExperimental Treatment3 Interventions

Participants will receive "real" tES (tDCS, tACS, tRNS) in which they receive up to 4 milliamps (mA) of stimulation per electrode for up to 40 minutes for up to 260 sessions. As this may be a cross-over design, some participants may receive active and sham conditions.

Group VII: Sham TESPlacebo Group3 Interventions

Participants undergoing this condition will have the exact same procedures as the active group, with the exception that they will receive only sham stimulation for up to 260 sessions.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sham tACS

2018

N/A

~50

Active tDCS

2012

Completed Phase 1

~1190