Patient-Centered NeuroRehabilitation (PCN)

Cognitive Deficit Clinical Trial

— PCN  

Official title:

Patient-Centered NeuroRehabilitation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03036319
• Other study ID #: HUM00111090
• Status: Recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: April 2026

Study information

• Verified date: November 2023
• Source: University of Michigan
• Contact: Kayla Rinna, M.S.
• Phone: 734-936-7739
• Email: krinna[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

1. Individuals who have reported cognitive dysfunction and cognitively intact participants.

2. Participants will be age 50 or older

Exclusion Criteria:

1. A history of serious mental illness (e.g., schizophrenia, axis 2 disorders)

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

3. A significant history or current use of 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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Deficit
• Cognitive Dysfunction

Intervention

Device:
• Active tDCS
Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.
• Sham tDCS
Participants will receive sham tDCS for up to 260 sessions

Behavioral:
• 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 for up to 260 sessions

Device:
• Active tACS
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
Participants will receive sham transcranial alternating current stimulation for up to 260 sessions
• Active tRNS
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
Participants will receive sham transcranial random noise stimulation for up to 260 sessions

Locations

Country	Name	City	State
United States	University of Michigan - Department of Psychiatry	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TES side effect questionnaire	Side effect questionnaire that asks participants to rate the severity of potential TES related side effects	Immediately following TES (<15 minutes)