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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre, post, and follow-up at up to 1 year post treatment
Awards & highlights

PCN Trial 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.Check my eligibility
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.See study design
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.

PCN Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 50 years old or older.

PCN Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
TES side effect questionnaire
Other outcome measures
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

PCN 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 3
~1150
Sham tDCS
2016
Completed Phase 1
~910

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,797 Previous Clinical Trials
6,377,558 Total Patients Enrolled
Benjamin M Hampstead, Ph.D.Principal InvestigatorUniversity of Michigan

Media Library

Active tACS Clinical Trial Eligibility Overview. Trial Name: NCT03036319 — N/A
Cognitive Impairment Research Study Groups: Sham TES + Cognitively based intervention, Cognitively based intervention, Active TES, Sham TES, Cognitively based interventions, Active TES, Sham TES, Active and Sham TES, Active TES + Cognitively based intervention
Cognitive Impairment Clinical Trial 2023: Active tACS Highlights & Side Effects. Trial Name: NCT03036319 — N/A
Active tACS 2023 Treatment Timeline for Medical Study. Trial Name: NCT03036319 — N/A

Frequently Asked Questions

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

Are there any remaining vacancies in this clinical experiment?

"Affirmative. The clinical trial data hosted on clinicaltrials.gov reveals that the study has been open for enrollment since June 1st 2016 and was last edited on November 23rd 2022. This investigation is currently looking to recruit 500 subjects from a single medical centre."

Answered by AI

How many people have enrolled for participation in this trial?

"Confirmed. According to the public data hosted on clinicaltrials.gov, this medical experiment was initially posted June 1st 2016 and has been recently updated November 23rd 2022. There is need for 500 test subjects across a single trial site in order to move forward with the project."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Patient-Centered NeuroRehabilitation (PCN)
Benjamin Hampstead, PhD 2016. "Patient-Centered NeuroRehabilitation (PCN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03036319.
~97 spots leftby Apr 2026
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