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

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.

Study Overview

• Status: Unknown
• Conditions: Cognitive Impairment; Traumatic Brain Injury
• Intervention / Treatment: Other: Real tRNS; Other: Sham tRNS

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Recruiting
      • Institut Guttmann
      • Contact: Jose Maria Tormos, Ph.D.; Phone Number: 2155 934 97 77 00; Email: jmtormos@guttmann.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Real tRNS; Real tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks.	Other: Real tRNS; 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.; Other Names: Guttmann, NeuroPersonalTrainer (GNPT)
Sham Comparator: Sham tRNS; Sham tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks.	Other: Sham tRNS; 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 .; Other Names: Guttmann, NeuroPersonalTrainer (GNPT)

What is the study measuring?

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
Stroop Color and Word test (Stroop Test)	To improve performance in inhibitory control	1 day
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

Collaborators and Investigators

• Sponsor: Institut Guttmann

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2019
• Primary Completion (Anticipated): September 1, 2019
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: October 3, 2018
• First Submitted That Met QC Criteria: October 3, 2018
• First Posted (Actual): October 4, 2018

Study Record Updates

• Last Update Posted (Actual): February 26, 2019
• Last Update Submitted That Met QC Criteria: February 25, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: traumatic brain injury; cognitive impairment; tbi; computerized cognitive rehabilitation; trns
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Craniocerebral Trauma; Trauma, Nervous System; Cognition Disorders; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Cognitive Dysfunction
• Other Study ID Numbers: 2018-281

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No