Back to resultsClinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury (TRUST)
Primary Purpose
Traumatic Brain Injury, Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Real tRNS
Sham tRNS
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring computerized cognitive rehabilitation, trns, traumatic brain injury, tbi, cognitive impairment
Eligibility 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.
Sites / Locations
- Institut GuttmannRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Real tRNS
Sham tRNS
Arm Description
Real tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks.
Sham tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks.
Outcomes
Primary Outcome Measures
Conners Continuous Performance Test (CPT-II)
To improve performance in sustained attention after receiving experimental intervention.
Digit Span Forward from the Wechsler Adult Intelligence Scale
To improve performance in span of immediate verbal recall after receiving experimental intervention.
Digit Span Backward from the Wechsler Adult Intelligence Scale
To improve performance in working memory after receiving experimental intervention.
Rey Auditory Verbal Learning Test
To improve performance in short-term, long-term and recognition.
Letters and Numbers from the Wechsler Adult Intelligence Scale
To improve performance in working memory after receiving experimental intervention.
Spanish phonemic fluency test (PMR)
To improve performance in phonemic fluency after receiving experimental intervention.
Secondary Outcome Measures
Trail Making Test A (TMT-A)
To improve performance in visual attention
Trail Making Test B (TMT-B)
To improve performance in task-switching
Wisconsin Card Sorting Test (WCST)
To improve performance in set-shifting
Stroop Color and Word test (Stroop Test)
To improve performance in inhibitory control
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03696381
Brief Title
Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury
Acronym
TRUST
Official Title
Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 25, 2019 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Guttmann
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Cognitive Impairment
Keywords
computerized cognitive rehabilitation, trns, traumatic brain injury, tbi, cognitive impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Real tRNS
Arm Type
Experimental
Arm Description
Real tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks.
Arm Title
Sham tRNS
Arm Type
Sham Comparator
Arm Description
Sham tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks.
Intervention Type
Other
Intervention Name(s)
Real tRNS
Other Intervention Name(s)
Guttmann, NeuroPersonalTrainer (GNPT)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham tRNS
Other Intervention Name(s)
Guttmann, NeuroPersonalTrainer (GNPT)
Intervention Description
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 .
Primary Outcome Measure Information:
Title
Conners Continuous Performance Test (CPT-II)
Description
To improve performance in sustained attention after receiving experimental intervention.
Time Frame
1 day
Title
Digit Span Forward from the Wechsler Adult Intelligence Scale
Description
To improve performance in span of immediate verbal recall after receiving experimental intervention.
Time Frame
1 day
Title
Digit Span Backward from the Wechsler Adult Intelligence Scale
Description
To improve performance in working memory after receiving experimental intervention.
Time Frame
1 day
Title
Rey Auditory Verbal Learning Test
Description
To improve performance in short-term, long-term and recognition.
Time Frame
1 day
Title
Letters and Numbers from the Wechsler Adult Intelligence Scale
Description
To improve performance in working memory after receiving experimental intervention.
Time Frame
1 day
Title
Spanish phonemic fluency test (PMR)
Description
To improve performance in phonemic fluency after receiving experimental intervention.
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Trail Making Test A (TMT-A)
Description
To improve performance in visual attention
Time Frame
1 day
Title
Trail Making Test B (TMT-B)
Description
To improve performance in task-switching
Time Frame
1 day
Title
Wisconsin Card Sorting Test (WCST)
Description
To improve performance in set-shifting
Time Frame
1 day
Title
Stroop Color and Word test (Stroop Test)
Description
To improve performance in inhibitory control
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adria Garcia Rosas
Phone
934977700
Email
adriagarcia@guttmann.com
Facility Information:
Facility Name
Institut Guttmann
City
Badalona
State/Province
Barcelona
ZIP/Postal Code
08916
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Maria Tormos, Ph.D.
Phone
934 97 77 00
Ext
2155
Email
jmtormos@guttmann.com
12. IPD Sharing Statement
Learn more about this trial
Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury
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