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

Not Applicable

• Conditions: Traumatic Brain Injury; Cognitive Impairment

• Registration Number: NCT03696381
• Lead Sponsor: Institut Guttmann

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-04
• Status Verified: 2019-02
• Study Start: 2019-02-25
• Last Update Submitted: 2019-02-25
• Last Update Posted: 2019-02-26
• Primary Completion: 2019-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Institut Guttmann; 🇪🇸 Badalona, Barcelona, Spain