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Patient Centered-Rehabilitation ver111090.1 (PCN1)

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University of Michigan

Status

Completed

Conditions

Cognitive Change

Treatments

Device: Sham HD-tDCS
Device: Active HD-tDCS

Study type

Interventional

Funder types

Other

Identifiers

NCT03034954
HUM00111090.1 PCN

Details and patient eligibility

About

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.

Full description

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.

Enrollment

42 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

42 participants in 2 patient groups

Active HD-tDCS
Active Comparator group
Description:
Participants will receive "real" HD-tDCS (3 milliamps for 20 minutes) for a single session.
Treatment:
Device: Active HD-tDCS
Sham HD-tDCS
Sham Comparator group
Description:
Participants will undergo the exact same procedures as the active group but will receive sham stimulation for a single session.
Treatment:
Device: Sham HD-tDCS

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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