Brain Stimulation for Traumatic Brain Injury (TMS/DAI)

August 11, 2017 updated by: Iuri Santana Neville Ribeiro, University of Sao Paulo

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 054010-000
        • Clinics Hospital - University of Sao Paulo Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Active Coil
The patients assigned to this group will undergo repetitive Transcranial Magnetic Stimulation over 10 sessions (each one with 2,000 pulses) on left dorsolateral prefrontal cortex.
Other: Active Coil
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 Comparator: Sham
The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.
Other: Sham
The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
One week and three months after rTMS.

Secondary Outcome Measures

Outcome Measure
Time Frame
Evidence of improvement on Executive Function processes measured by cognitive evaluation.
Time Frame: one week and 3 months.
one week and 3 months.
Evidence of improvement on Motor Coordination measured by cognitive evaluation.
Time Frame: one week and three months.
one week and three months.
Changes in cortical excitability measured by single and paired-pulse TMS
Time Frame: one week and three months.
one week and three months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo

Investigators

  • Study Chair: Wellingson S Paiva, MD, University of Sao Paulo
  • Principal Investigator: Iuri N Ribeiro, MD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 17, 2014

First Posted (Estimate)

June 19, 2014

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 11, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USP-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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