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

Traumatic Brain Injury Clinical Trial

— TRUST  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03696381
• Other study ID #: 2018-281
• Status: Recruiting
• Phase: N/A
• Start date: February 25, 2019
• Est. completion date: December 2020

Study information

• Verified date: February 2019
• Source: Institut Guttmann
• Contact: Adria Garcia Rosas
• Phone: 934977700
• Email: adriagarcia[@]guttmann.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Cognitive Dysfunction
• Cognitive Impairment
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.
• 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 .

Locations

Country	Name	City	State
Spain	Institut Guttmann	Badalona	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Guttmann

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conners Continuous Performance Test (CPT-II)	To improve performance in sustained attention after receiving experimental intervention.	1 day
Primary	Digit Span Forward from the Wechsler Adult Intelligence Scale	To improve performance in span of immediate verbal recall after receiving experimental intervention.	1 day
Primary	Digit Span Backward from the Wechsler Adult Intelligence Scale	To improve performance in working memory after receiving experimental intervention.	1 day
Primary	Rey Auditory Verbal Learning Test	To improve performance in short-term, long-term and recognition.	1 day
Primary	Letters and Numbers from the Wechsler Adult Intelligence Scale	To improve performance in working memory after receiving experimental intervention.	1 day
Primary	Spanish phonemic fluency test (PMR)	To improve performance in phonemic fluency after receiving experimental intervention.	1 day
Secondary	Trail Making Test A (TMT-A)	To improve performance in visual attention	1 day
Secondary	Trail Making Test B (TMT-B)	To improve performance in task-switching	1 day
Secondary	Wisconsin Card Sorting Test (WCST)	To improve performance in set-shifting	1 day
Secondary	Stroop Color and Word test (Stroop Test)	To improve performance in inhibitory control	1 day