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

Study Overview
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Brief Summary
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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.

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

Conditions
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Traumatic Brain Injury, Cognitive Impairment

Intervention / Treatment
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* Other: Real tRNS
* Other: Sham tRNS


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real tRNS<br>Real tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks. | Other: Real tRNS<br>* The treatment consists of a set of 1-h sessions, three sessions per week for 8 weeks. A series of cognitive exercises of attention, memory, and executive functions will be conducted in each session. During the first 20 minutes of each cognitive training session, patients will receive bi-frontal and bi-parietal tRNS. It has a start and end ramp of two seconds in each case to avoid the slight unpleasant sensation that occurs in the first moments of the introduction of direct current DC.<br>* Other names: Guttmann, NeuroPersonalTrainer (GNPT);|
| Sham Comparator: Sham tRNS<br>Sham tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks. | Other: Sham tRNS<br>* The treatment consists of a set of 1-h sessions, three sessions per week for 8 weeks. A series of cognitive exercises of attention, memory, and executive functions will be conducted in each session. We will apply a sham tRNS for the first 20 minutes of each cognitive training session. The subjects will receive sham tRNS and will perform the same type of cognitive training as the rest of patients and will receive the same type of adverse reaction questionnaire. Subjects receiving simulated stimulation will receive the same type of ramps at the beginning and end of the session to ensure triple-blind maintenance .<br>* Other names: Guttmann, NeuroPersonalTrainer (GNPT);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Conners Continuous Performance Test (CPT-II) | To improve performance in sustained attention after receiving experimental intervention. | 1 day | 
| Digit Span Forward from the Wechsler Adult Intelligence Scale | To improve performance in span of immediate verbal recall after receiving experimental intervention. | 1 day | 
| Digit Span Backward from the Wechsler Adult Intelligence Scale | To improve performance in working memory after receiving experimental intervention. | 1 day | 
| Rey Auditory Verbal Learning Test | To improve performance in short-term, long-term and recognition. | 1 day | 
| Letters and Numbers from the Wechsler Adult Intelligence Scale | To improve performance in working memory after receiving experimental intervention. | 1 day | 
| Spanish phonemic fluency test (PMR) | To improve performance in phonemic fluency after receiving experimental intervention. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Trail Making Test A (TMT-A) | To improve performance in visual attention | 1 day | 
| Trail Making Test B (TMT-B) | To improve performance in task-switching | 1 day | 
| Wisconsin Card Sorting Test (WCST) | To improve performance in set-shifting | 1 day | 
| Stroop Color and Word test (Stroop Test) | To improve performance in inhibitory control | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tbi, computerized cognitive rehabilitation, trns, traumatic brain injury, cognitive impairment