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Brain Stimulation for Traumatic Brain Injury (TMS/DAI)

Primary Purpose

Traumatic Brain Injury, Diffuse Axonal Injury

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Active Coil
Sham
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury focused on measuring traumatic brain injury, diffuse axonal injury, repetitive transcranial magnetic stimulation, neuromodulation, cognitive rehabilitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinics Hospital - University of Sao Paulo Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active Coil

Sham

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evidence of improvement on Executive Function processes measured by cognitive evaluation.
Evidence of improvement on Motor Coordination measured by cognitive evaluation.
Changes in cortical excitability measured by single and paired-pulse TMS

Full Information

First Posted
June 17, 2014
Last Updated
August 11, 2017
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT02167971
Brief Title
Brain Stimulation for Traumatic Brain Injury
Acronym
TMS/DAI
Official Title
Evaluation of Repetitive Transcranial Magnetic Stimulation on the Cognitive Rehabilitation After Traumatic Diffuse Axonal Injury.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Diffuse Axonal Injury
Keywords
traumatic brain injury, diffuse axonal injury, repetitive transcranial magnetic stimulation, neuromodulation, cognitive rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Coil
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham
Arm Type
Sham Comparator
Arm Description
The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.
Intervention Type
Other
Intervention Name(s)
Active Coil
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Evidence of improvement on Executive Function processes measured by cognitive evaluation.
Time Frame
one week and 3 months.
Title
Evidence of improvement on Motor Coordination measured by cognitive evaluation.
Time Frame
one week and three months.
Title
Changes in cortical excitability measured by single and paired-pulse TMS
Time Frame
one week and three months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wellingson S Paiva, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Iuri N Ribeiro, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinics Hospital - University of Sao Paulo Medical School
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
054010-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
33343483
Citation
Rodrigues PA, Zaninotto AL, Ventresca HM, Neville IS, Hayashi CY, Brunoni AR, de Paula Guirado VM, Teixeira MJ, Paiva WS. The Effects of Repetitive Transcranial Magnetic Stimulation on Anxiety in Patients With Moderate to Severe Traumatic Brain Injury: A Post-hoc Analysis of a Randomized Clinical Trial. Front Neurol. 2020 Dec 4;11:564940. doi: 10.3389/fneur.2020.564940. eCollection 2020.
Results Reference
derived
PubMed Identifier
31175209
Citation
Neville IS, Zaninotto AL, Hayashi CY, Rodrigues PA, Galhardoni R, Ciampi de Andrade D, Brunoni AR, Amorim RLO, Teixeira MJ, Paiva WS. Repetitive TMS does not improve cognition in patients with TBI: A randomized double-blind trial. Neurology. 2019 Jul 9;93(2):e190-e199. doi: 10.1212/WNL.0000000000007748. Epub 2019 Jun 7.
Results Reference
derived
PubMed Identifier
26438108
Citation
Neville IS, Hayashi CY, El Hajj SA, Zaninotto AL, Sabino JP, Sousa LM Jr, Nagumo MM, Brunoni AR, Shieh BD, Amorim RL, Teixeira MJ, Paiva WS. Repetitive Transcranial Magnetic Stimulation (rTMS) for the cognitive rehabilitation of traumatic brain injury (TBI) victims: study protocol for a randomized controlled trial. Trials. 2015 Oct 5;16:440. doi: 10.1186/s13063-015-0944-2.
Results Reference
derived

Learn more about this trial

Brain Stimulation for Traumatic Brain Injury

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