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Brain Stimulation for Traumatic Brain Injury

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02167971
Acronym
TMS/DAI
Enrollment
30
Registered
2014-06-19
Start date
2014-01-31
Completion date
2017-08-31
Last updated
2017-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Axonal Injury, Traumatic Brain Injury

Keywords

traumatic brain injury, diffuse axonal injury, repetitive transcranial magnetic stimulation, neuromodulation, cognitive rehabilitation

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).

Interventions

OTHERActive 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.

OTHERSham

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

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime 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)One week and three months after rTMS.

Secondary

MeasureTime frame
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 TMSone week and three months.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026