Clinical Trial of The Boosting Effect of Transcranial Random Noise Stimulation (tRNS) in Cognitive Rehabilitation of Patients With Traumatic Brain Injury
TRUST
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2018
CompletedFirst Posted
Study publicly available on registry
October 4, 2018
CompletedStudy Start
First participant enrolled
February 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedFebruary 26, 2019
February 1, 2019
6 months
October 3, 2018
February 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Conners Continuous Performance Test (CPT-II)
To improve performance in sustained attention after receiving experimental intervention.
1 day
Digit Span Forward from the Wechsler Adult Intelligence Scale
To improve performance in span of immediate verbal recall after receiving experimental intervention.
1 day
Digit Span Backward from the Wechsler Adult Intelligence Scale
To improve performance in working memory after receiving experimental intervention.
1 day
Rey Auditory Verbal Learning Test
To improve performance in short-term, long-term and recognition.
1 day
Letters and Numbers from the Wechsler Adult Intelligence Scale
To improve performance in working memory after receiving experimental intervention.
1 day
Spanish phonemic fluency test (PMR)
To improve performance in phonemic fluency after receiving experimental intervention.
1 day
Secondary Outcomes (4)
Trail Making Test A (TMT-A)
1 day
Trail Making Test B (TMT-B)
1 day
Wisconsin Card Sorting Test (WCST)
1 day
Stroop Color and Word test (Stroop Test)
1 day
Study Arms (2)
Real tRNS
EXPERIMENTALReal tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks.
Sham tRNS
SHAM COMPARATORSham tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks.
Interventions
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.
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 .
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institut Guttmann
Badalona, Barcelona, 08916, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD Student
Study Record Dates
First Submitted
October 3, 2018
First Posted
October 4, 2018
Study Start
February 25, 2019
Primary Completion
September 1, 2019
Study Completion
December 1, 2020
Last Updated
February 26, 2019
Record last verified: 2019-02