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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Adria Garcia Rosas，Institut Guttmann

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

September 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Conners Continuous Performance Test (CPT-II)[ Time Frame: 1 day ]

To improve performance in sustained attention after receiving experimental intervention.

Digit Span Forward from the Wechsler Adult Intelligence Scale[ Time Frame: 1 day ]

To improve performance in span of immediate verbal recall after receiving experimental intervention.

Digit Span Backward from the Wechsler Adult Intelligence Scale[ Time Frame: 1 day ]

To improve performance in working memory after receiving experimental intervention.

Rey Auditory Verbal Learning Test[ Time Frame: 1 day ]

To improve performance in short-term, long-term and recognition.

Letters and Numbers from the Wechsler Adult Intelligence Scale[ Time Frame: 1 day ]

To improve performance in working memory after receiving experimental intervention.

Spanish phonemic fluency test (PMR)[ Time Frame: 1 day ]

To improve performance in phonemic fluency after receiving experimental intervention.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

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: 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 .

Study Arms

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

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2020

Estimated Primary Completion Date

September 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Spain

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Adria Garcia Rosas，Institut Guttmann

Study Sponsor ^ICMJE

Institut Guttmann

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

Institut Guttmann

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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