Patient-Centered NeuroRehabilitation (PCN)

Not Applicable

Recruiting

• Conditions: Cognitive Deficit
• Interventions: Device: Active tDCS; Device: Sham tDCS; Device: Active tACS; Device: Sham tACS; Behavioral: Cognitively based intervention; Device: Sham tRNS; Device: Active tRNS

• Registration Number: NCT03036319
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

The primary objective of this study is to evaluate the feasibility of a neurorehabilitation treatment tailored to individual patient needs, with the ultimate goal of maximizing cognitive and real-world functioning for older adults with cognitive aging, mild cognitive impairment (MCI), neurodegenerative, or other neurological diseases/conditions.

Transcranial electrical stimulation (TES) is a non-invasive, neurorehabilitation procedure in which a weak electric current is passed between electrodes that are placed on the scalp with the intention of modulating excitability of the underlying brain regions. Because the field of TES is relatively young, rapidly evolving, and primarily focused on cognitive neuroscience with "healthy" individuals, there is a clear need for well-conceptualized and conducted clinical research. The current protocol is intentionally broad with respect to both methodology and patient characteristics in order to tailor potential TES interventions to individual patients or small samples. The current protocol utilizes various forms of TES including transcranial direct current stimulation (tDCS), alternating current stimulation (tACS), and random noise stimulation (tRNS) and sham stimulation in older adults. As this is a cross-over design, some participants may receive active (or "real") TES and/or sham TES conditions.This includes head to head comparisons of the different forms of TES. Additionally, TES could be performed in conjunction with cognitively-based intervention since this may enhance the neuroplastic response of the targeted brain region(s) while at the same time shaping/optimizing the pathways that are engaged by cognitively-based interventions. This broad approach is important since etiological differences in cognitive impairment may necessitate distinct interventions.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2017-01-25
• Study First Submitted QC: 2017-01-25
• Study First Posted: 2017-01-30
• Status Verified: 2023-11
• Last Update Submitted: 2024-11-26
• Last Update Posted: 2024-11-28
• Primary Completion: 2026-04
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

1. Individuals who have reported cognitive dysfunction and cognitively intact participants.
2. Participants will be age 50 or older

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Exclusion Criteria

1. A history of epilepsy
2. Sensory or motor impairments that limit the ability to take part in the study
3. Current alcohol or drug abuse/dependence
4. 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)

Those who are being evaluated for TES methodology will also be excluded for 1) metallic or electronic implant 2) skull plates or other cranial implants that affect TES

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Active TES + Cognitively based intervention	Active tRNS	This condition combines active TES and cognitively based interventions for some or all of the study sessions
Active and Sham TES	Active tRNS	Participants will receive active and sham TES
Active TES	Active tDCS	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.
Active and Sham TES	Active tDCS	Participants will receive active and sham TES
Sham TES + Cognitively based intervention	Sham tDCS	This condition combines sham TES and cognitively based interventions for some or all of the study sessions
Active TES	Active tACS	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.
Sham TES	Sham tACS	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.
Sham TES + Cognitively based intervention	Cognitively based intervention	This condition combines sham TES and cognitively based interventions for some or all of the study sessions
Active TES, Sham TES, Cognitively based interventions	Sham tDCS	This condition combines active and sham TES with cognitively based interventions using a cross-over design
Active TES, Sham TES, Cognitively based interventions	Active tRNS	This condition combines active and sham TES with cognitively based interventions using a cross-over design
Active TES, Sham TES, Cognitively based interventions	Sham tACS	This condition combines active and sham TES with cognitively based interventions using a cross-over design
Active TES	Active tRNS	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.
Sham TES	Sham tDCS	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.
Sham TES	Sham tRNS	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.
Cognitively based intervention	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.
Active TES + Cognitively based intervention	Active tACS	This condition combines active TES and cognitively based interventions for some or all of the study sessions
Sham TES + Cognitively based intervention	Sham tACS	This condition combines sham TES and cognitively based interventions for some or all of the study sessions
Sham TES + Cognitively based intervention	Sham tRNS	This condition combines sham TES and cognitively based interventions for some or all of the study sessions
Active TES, Sham TES, Cognitively based interventions	Active tDCS	This condition combines active and sham TES with cognitively based interventions using a cross-over design
Active TES, Sham TES, Cognitively based interventions	Cognitively based intervention	This condition combines active and sham TES with cognitively based interventions using a cross-over design
Active TES, Sham TES, Cognitively based interventions	Active tACS	This condition combines active and sham TES with cognitively based interventions using a cross-over design
Active and Sham TES	Active tACS	Participants will receive active and sham TES
Active and Sham TES	Sham tRNS	Participants will receive active and sham TES
Active TES + Cognitively based intervention	Active tDCS	This condition combines active TES and cognitively based interventions for some or all of the study sessions
Active and Sham TES	Sham tDCS	Participants will receive active and sham TES
Active and Sham TES	Sham tACS	Participants will receive active and sham TES
Active TES + Cognitively based intervention	Cognitively based intervention	This condition combines active TES and cognitively based interventions for some or all of the study sessions
Active TES, Sham TES, Cognitively based interventions	Sham tRNS	This condition combines active and sham TES with cognitively based interventions using a cross-over design

Primary Outcome Measures

Name	Time	Method
TES side effect questionnaire	Immediately following TES (<15 minutes)	Side effect questionnaire that asks participants to rate the severity of potential TES related side effects

Trial Locations

Locations (1)

University of Michigan - Department of Psychiatry; 🇺🇸 Ann Arbor, Michigan, United States