Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury (TRUST)

Guttmann Institute

Status: Unknown

Conditions: Traumatic Brain Injury; Cognitive Impairment

Treatments: Other: Sham tRNS; Other: Real tRNS

Study type: Interventional

Funder types: Other

Identifiers

NCT03696381

2018-281

Details and patient eligibility

About

The main objective of this study is to evaluate the effects of tRNS while undergoing computerized cognitive rehabilitation therapy to conclude if this combination of therapies would be effective for the cognitive rehabilitation of patients with acquired brain damage, such as traumatic brain injury. We want to study the therapeutic potential of tRNS to enhance the therapeutic outcome of cognitive training, studying its global effect over the rehabilitation of attention, memory and executive functions, compared to sham tRNS.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 18 years old
• documented history of severe or moderate TBI (severe TBI: Glasgow Coma Scale 3-8; moderate TBI: Glasgow Coma Scale 9-13)
• out of post-traumatic amnesia
• less than 6 months after TBI
• cognitive impairment objectified by neuropsychological exploration.

Exclusion criteria

• impairment of language, affecting the production and/or comprehension of speech and the ability to read and/or write
• severe alteration of the visual field or visual perception problems that limits the use of technological devices
• sever motor impairment of both upper extremities that prevent the use of technological devices
• previous or current history of psychiatric, neurological or systemic alterations that affect the central nervous system
• history of substance abuse
• dermatological diseases in the skull
• presence of metal implants or holes in the skull
• epilepsy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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30 participants in 2 patient groups

Real tRNS

Experimental group

Description:

Real tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks.

Treatment:

Other: Real tRNS

Sham tRNS

Sham Comparator group

Description:

Sham tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks.

Treatment:

Other: Sham tRNS