NCT02167971

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2014

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2014

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 15, 2017

Status Verified

August 1, 2017

Enrollment Period

3.6 years

First QC Date

June 17, 2014

Last Update Submit

August 11, 2017

Conditions

Traumatic Brain InjuryDiffuse Axonal Injury

Keywords

traumatic brain injurydiffuse axonal injuryrepetitive transcranial magnetic stimulationneuromodulationcognitive rehabilitation

Outcome Measures

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)

    One week and three months after rTMS.

Secondary Outcomes (3)

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

    one week and 3 months.

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

    one week and three months.

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

    one week and three months.

Study Arms (2)

Active Coil

EXPERIMENTAL

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

Sham

SHAM COMPARATOR

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

Interventions

Active CoilOTHER

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.

Active Coil
ShamOTHER

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

Sham

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Drug addiction
  • Uncontrolled epilepsy
  • Extensive Cranial vault defects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinics Hospital - University of Sao Paulo Medical School

São Paulo, São Paulo, 054010-000, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 33343483DERIVED

  • 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.

    PMID: 31175209DERIVED

  • 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.

    PMID: 26438108DERIVED

MeSH Terms

Conditions

Brain Injuries, TraumaticDiffuse Axonal Injury

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBrain Injuries, Diffuse

Study Officials

  • Wellingson S Paiva, MD

    University of Sao Paulo

    STUDY CHAIR

  • Iuri N Ribeiro, MD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
iurineville

Study Record Dates

First Submitted

June 17, 2014

First Posted

June 19, 2014

Study Start

January 1, 2014

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

August 15, 2017

Record last verified: 2017-08

Locations

BR(1)