Brain Stimulation for Traumatic Brain Injury (TMS/DAI)

University of Sao Paulo

Status and phase: Completed; Phase 2

Conditions: Traumatic Brain Injury; Diffuse Axonal Injury

Treatments: Other: Active Coil; Other: Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT02167971

USP-01

Details and patient eligibility

About

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).

Enrollment: 30 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Active Coil

Experimental group

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.

Treatment:

Other: Active Coil

Sham

Sham Comparator group

Description:

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

Treatment:

Other: Sham