Brain Stimulation for Traumatic Brain Injury

Traumatic Brain Injury Clinical Trial

— TMS/DAI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167971
• Other study ID #: USP-01
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2014
• Last updated: August 11, 2017
• Start date: January 2014
• Est. completion date: August 2017

Study information

• Verified date: August 2017
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Diffuse Axonal Injury
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Brazil	Clinics Hospital - University of Sao Paulo Medical School	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Evidence of improvement on Executive Function processes measured by cognitive evaluation.		one week and 3 months.
Secondary	Evidence of improvement on Motor Coordination measured by cognitive evaluation.		one week and three months.
Secondary	Changes in cortical excitability measured by single and paired-pulse TMS		one week and three months.