Health TrialsbyHealthPanel

Patient-Centered NeuroRehabilitation (PCN)

ConditionCognitive Deficit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversity of Michigan

About this trial

As individuals grow older, a number of factors can reduce our cognitive (or thinking) abilities such as "normal" aging, neurodegenerative diseases, and cardiovascular disease. This study will evaluate whether cognitive rehabilitation and transcranial electrical stimulation (TES) can improve cognitive abilities. Cognitive rehabilitation refers to methods that are used to improve tasks people have trouble doing in everyday life. Transcranial electrical stimulation uses small amounts of electricity to try to alter brain functioning. These approaches may help improve cognitive abilities like attention, learning, memory, finding words, and problem solving as well as everyday functioning. The goal of this study is to identify how to best use these methods, either alone or in combination.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Individuals who have reported cognitive dysfunction and cognitively intact participants.

Participants will be age 50 or older

Disqualifiers

A history of epilepsy

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

Current alcohol or drug abuse/dependence

Those who are currently pregnant or may become pregnant during the duration of the study (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge)

Trial design

Design model

Single group

Treatments tested in this trial

  • Active tDCS

    Device

    Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.

  • Sham tDCS

    Device

    Participants will receive sham tDCS for up to 260 sessions

  • Cognitively based intervention

    Behavioral

    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 for up to 260 sessions

  • Active tACS

    Device

    Participants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions

  • Sham tACS

    Device

    Participants will receive sham transcranial alternating current stimulation for up to 260 sessions

  • Active tRNS

    Device

    Participants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions

  • Sham tRNS

    Device

    Participants will receive sham transcranial random noise stimulation for up to 260 sessions

Treatment groups

500 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Active TESExperimental treatment 3 interventions
Group B: Sham TESPlacebo comparator 3 interventions
Group C: Cognitively based interventionExperimental treatment 1 intervention
Group D: Active TES + Cognitively based interventionExperimental treatment 4 interventions
Group E: Sham TES + Cognitively based interventionExperimental treatment 4 interventions
Group F: Active TES, Sham TES, Cognitively based interventionsExperimental treatment 7 interventions
Group G: Active and Sham TESExperimental treatment 6 interventions

Trial outcomes

Primary outcomes

1

TES side effect questionnaire

Side effect questionnaire that asks participants to rate the severity of potential TES related side effects

Time frame
Immediately following TES (<15 minutes)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Source ClinicalTrials.gov
Apply now