Patient Centered-Rehabilitation ver111090.1

NCT ID: NCT03034954

Last Updated: 2018-08-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-10-31

Brief Summary

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As we age, a number of factors can reduce our cognitive (or thinking) abilities. This study will evaluate whether transcranial electrical stimulation (TES), which uses small amounts of electricity to modulate brain functioning, can improve cognitive abilities. Here, the effects of TES on working memory, learning, and memory, will be evaluated in a group of healthy older adults.

Detailed Description

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The primary objective is to investigate the cognitive effects of high definition anodal tDCS (HD-tDCS; anode at center electrode) at 3 mA (for 20 minutes) on learning, memory, and working memory. Participants will be randomized to active or sham stimulation and will complete a series of cognitive tests both during and after stimulation.

Tolerability and blinding will also be evaluated using standard side effect questionnaires.

Conditions

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Cognitive Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Active HD-tDCS

Participants will receive "real" HD-tDCS (3 milliamps for 20 minutes) for a single session.

Group Type ACTIVE_COMPARATOR

Active HD-tDCS

Intervention Type DEVICE

Participants will receive active HD-tDCS at 3mA for 20 minutes

Sham HD-tDCS

Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.

Group Type SHAM_COMPARATOR

Sham HD-tDCS

Intervention Type DEVICE

Participants will receive sham HD-tDCS

Interventions

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Active HD-tDCS

Participants will receive active HD-tDCS at 3mA for 20 minutes

Intervention Type DEVICE

Sham HD-tDCS

Participants will receive sham HD-tDCS

Intervention Type DEVICE

Other Intervention Names

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HD-tDCS

Eligibility Criteria

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Inclusion Criteria

1. Individuals with intact cognitive functioning.
2. Participants will be age 50 or older.

Exclusion Criteria

1. Individuals with a documented history of cognitive impairment.
2. A history of serious mental illness (e.g., bipolar disorder, schizophrenia, axis 2 disorders)
3. Sensory or motor impairments that limit the ability to take part in the study
4. A significant history or current use of alcohol or drug abuse/dependence
5. Those who are currently pregnant (if there is a question of pregnancy, pregnancy tests will be available for participants at no charge)
6. Participants with an Mini Mental State Examination score \<24 at screening.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Benjamin Hampstead, PhD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benjamin M Hampstead, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan - Department of Psychiatry

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

References

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Brunoni AR, Amadera J, Berbel B, Volz MS, Rizzerio BG, Fregni F. A systematic review on reporting and assessment of adverse effects associated with transcranial direct current stimulation. Int J Neuropsychopharmacol. 2011 Sep;14(8):1133-45. doi: 10.1017/S1461145710001690. Epub 2011 Feb 15.

Reference Type BACKGROUND
PMID: 21320389 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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HUM00111090.1 PCN

Identifier Type: -

Identifier Source: org_study_id

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