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Completed

NCT Number: NCT02167971

Brain Stimulation for Traumatic Brain Injury

The purpose of this study is to determine whether repetitive Transcranial Magnetic Stimulation (rTMS) is effective in the cognitive rehabilitation of patients with diffuse axonal injury(DAI) after Traumatic Brain Injury(TBI).

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Diffuse Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Diffuse Axonal Injury Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Clinics Hospital - University of Sao Paulo Medical School

São Paulo, 054010-000, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical and radiological diagnosis of traumatic brain injury.
  • Between one to two years after traumatic brain injuri
  • Must be able to sign the Informed Consent Form

Exclusion criteria

  • Drug addiction
  • Uncontrolled epilepsy
  • Extensive Cranial vault defects

Treatment and study plan

Active Coil

Other

The patients will undergo 10 sessions (2,000 pulses each, lasting 20 minutes) of repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex with the following parameters: 10Hz, 50 trains (40 pulses on each train), biphasic wave, 25 seconds between the trains.

SHAM

Other

The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.

Primary outcomes

  1. Evidence of improvement on Attentional processes measured by cognitive evaluation (Trail Making Test parts A and B; Stroop Test - Victoria Version; Symbol Digit Test)

    Time frame: One week and three months after rTMS.

Secondary outcomes

  1. Evidence of improvement on Executive Function processes measured by cognitive evaluation.

    Time frame: one week and 3 months.

  2. Evidence of improvement on Motor Coordination measured by cognitive evaluation.

    Time frame: one week and three months.

  3. Changes in cortical excitability measured by single and paired-pulse TMS

    Time frame: one week and three months.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Evaluation of Repetitive Transcranial Magnetic Stimulation on the Cognitive Rehabilitation After Traumatic Diffuse Axonal Injury.

Acronym: TMS/DAI

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 19, 2014
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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