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

NCT02549560 | Completed DMC

• 1 other identifier: Transcranial Stimulation
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

tDCS; Cardiac Surgery

Outcome Measures

Primary Outcomes (1)

• tDCS as a cognitive enhancer for patients with postoperative cognitive dysfunction after cardiac surgery

  Evaluate if tDCS sessions decrease the occurrence of POCD in patients submitted to extracorporeal circulation on cardiac surgery. Neuropsychological testing: Changes in results from neuropsychological assessment pre (before the first stimulation) to post treatment (after the last stimulation). There will be a eight days time frame from pre assessment to post assessment. The improvement of the skills and cognitive functions will be compare with results of tests for evaluation of quality of life, depressive symptoms and neuropsychological battery to assess, attention, visuospatial perception, immediate memory, operational, long-term memory and executive skills and recall, including processing speed.

  18 months

Secondary Outcomes (1)

• Changes in results from neuropsychological assessment pre (before the first stimulation) to post treatment (after the last stimulation).

  15 days

Study Arms (2)

tDCS GROUP

ACTIVE COMPARATOR

These patients will be submitted to 2 daily sessions of cerebral stimulation, starting from the first day after the surgery, for 4 consecutive days, with each session having 20 minutes, and a minimum break of 8 hours between them. Will be applied a direct current stimulus of 2 milliampere (mA) in the right anode and in the left cathode on the prefrontal right region.

Device: tDCS

CONTROL GROUP

SHAM COMPARATOR

In these patients will be applied, with the same equipment used in tDCS, a simulated stimulus similar to the active one. They will also be submitted to some psychological test to evaluate theirs mnemonics, attentional, executive and global functions.

Device: tDCS

Interventions

tDCS DEVICE

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.

Also known as: transcranial Direct Current Stimulation

CONTROL GROUP; tDCS GROUP

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over 18 years candidates do cardiac surgeries with extracorporeal circulation. Patients that signed the Free and Clarified Consent Form

You may not qualify if:

• Historic of progressive mental disease or dementia
• Psychiatric disease that affects cognition
• Lack of fluency of the Portuguese language
• Historic of epilepsies, convulsions, fainting and syncope
• With serious cranial traumas, carriers of ventriculoperitoneal derivation valves or metallic objects implanted in the brain
• With hearing problems or cochlear implants
• With cardiac pacemaker or any metallic implants in the body; Use of neuropsychiatric medications on the preoperative period
• Already submitted to the stimulation of the tDCS

Sponsors & Collaborators

• University of Sao Paulo: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

Livia Stocco Sanches Valentin

São Paulo, 02019010, Brazil

Location

Related Publications (31)

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MeSH Terms

Conditions

Postoperative Cognitive Complications

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Livia S Valentin, Ph.D.

  University of Sao Paulo School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: September 5, 2015
• First Posted: September 15, 2015
• Study Start: July 8, 2021
• Primary Completion: December 29, 2022
• Study Completion: November 8, 2023
• Last Updated: March 7, 2024

Record last verified: 2024-03

Locations

BR (1)