Patient-Centered NeuroRehabilitation (PCN)

Conditions

• Cognitive Deficit

Eligibility Criteria

Sex

ALL

Age

50 Years - N/A

Healthy Volunteers

Accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Jun 30, 2016

Status verified

Jan 2026

Primary completion

Nov 30, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

500 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Active TES
  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.
• Placebo Comparator: Sham TES
  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.
• Experimental: Cognitively based 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.
• Experimental: Active TES + Cognitively based intervention
  This condition combines active TES and cognitively based interventions for some or all of the study sessions
• Experimental: Sham TES + Cognitively based intervention
  This condition combines sham TES and cognitively based interventions for some or all of the study sessions
• Experimental: Active TES, Sham TES, Cognitively based interventions
  This condition combines active and sham TES with cognitively based interventions using a cross-over design
• Experimental: Active and Sham TES
  Participants will receive active and sham TES

Primary Outcome Measure

TES side effect questionnaire [ Time Frame: Immediately following TES (<15 minutes) ]

Central Contacts

• Kayla Rinna, M.S.
  734-936-7739
  [email protected]
• Eileen Robinson, RN, MPH
  734-763-1356
  [email protected]

Locations (1)

Find similar trials in Ann Arbor, MI

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