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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 (TRUST)

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ClinicalTrials.gov Identifier: NCT03696381
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : February 26, 2019
Sponsor:
Information provided by (Responsible Party):
Adria Garcia Rosas, 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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Cognitive Impairment Other: Real tRNS Other: Sham tRNS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury
Actual Study Start Date : February 25, 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Guttmann, NeuroPersonalTrainer (GNPT)




Primary Outcome Measures :
  1. Conners Continuous Performance Test (CPT-II) [ Time Frame: 1 day ]
    To improve performance in sustained attention after receiving experimental intervention.

  2. 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.

  3. Digit Span Backward from the Wechsler Adult Intelligence Scale [ Time Frame: 1 day ]
    To improve performance in working memory after receiving experimental intervention.

  4. Rey Auditory Verbal Learning Test [ Time Frame: 1 day ]
    To improve performance in short-term, long-term and recognition.

  5. Letters and Numbers from the Wechsler Adult Intelligence Scale [ Time Frame: 1 day ]
    To improve performance in working memory after receiving experimental intervention.

  6. Spanish phonemic fluency test (PMR) [ Time Frame: 1 day ]
    To improve performance in phonemic fluency after receiving experimental intervention.


Secondary Outcome Measures :
  1. Trail Making Test A (TMT-A) [ Time Frame: 1 day ]
    To improve performance in visual attention

  2. Trail Making Test B (TMT-B) [ Time Frame: 1 day ]
    To improve performance in task-switching

  3. Wisconsin Card Sorting Test (WCST) [ Time Frame: 1 day ]
    To improve performance in set-shifting

  4. Stroop Color and Word test (Stroop Test) [ Time Frame: 1 day ]
    To improve performance in inhibitory control



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696381


Contacts
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Contact: Adria Garcia Rosas 934977700 adriagarcia@guttmann.com

Locations
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Spain
Institut Guttmann Recruiting
Badalona, Barcelona, Spain, 08916
Contact: Jose Maria Tormos, Ph.D.    934 97 77 00 ext 2155    jmtormos@guttmann.com   
Sponsors and Collaborators
Institut Guttmann

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Responsible Party: Adria Garcia Rosas, PhD Student, Institut Guttmann
ClinicalTrials.gov Identifier: NCT03696381     History of Changes
Other Study ID Numbers: 2018-281
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: February 26, 2019
Last Verified: February 2019

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

Keywords provided by Adria Garcia Rosas, Institut Guttmann:
computerized cognitive rehabilitation
trns
traumatic brain injury
tbi
cognitive impairment

Additional relevant MeSH terms:
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Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Craniocerebral Trauma
Trauma, Nervous System
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders