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Effects of the Transcranial Stimulation on Prevention of Cognitive Dysfunction in Cardiac Surgery

NCT02549560 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2024-03-07

No results posted yet for this study

Summary

Postoperative cognitive dysfunction (POCD) is a contrary event observed between 20 to 83%, especially on elderly and patients submitted to cardiac surgery. The prevention and rehabilitation on cases of POCD can improve the quality of life and decrease the mortality in surgical patients. The effect of the noninvasive cerebral stimulation, also known as transcranial Direct Current Stimulation (tDCS) has been studied to be used in the treatment of brain injuries and depression, and also in the cognitive rehabilitation. The hypothesis is that the use of the tDCS technique can decrease the occurrence of POCD and cognitively rehabilitate patients submitted to cardiac surgeries.

Conditions

  • Postoperative Cognitive Dysfunction

Interventions

DEVICE

tDCS

Application of two daily sessions of cerebral stimulation starting from the first day after de surgery, for 4 consecutive days, with each session having 20 minutes, having an 8 hour minimum break between them. Will be applied a direct current stimulus of 2 milliampere (mA) (right anode/left cathode) in the prefrontal right region.

Sponsors & Collaborators

  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER

  • University of Sao Paulo

    lead OTHER

Principal Investigators

  • Livia S Valentin, Ph.D. · University of Sao Paulo School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-08
Primary Completion
2022-12-29
Completion
2023-11-08

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02549560 on ClinicalTrials.gov