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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Real tRNS | Experimental | Real tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks. |
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| Sham tRNS | Sham Comparator | Sham tRNS + Guttmann NeuroPersonalTrainer (GNPT) 3 days per week over 8 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real tRNS | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Trail Making Test A (TMT-A) | To improve performance in visual attention | 1 day |
| Trail Making Test B (TMT-B) | To improve performance in task-switching |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Adria Garcia Rosas | Contact | 934977700 | adriagarcia@guttmann.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Guttmann | Recruiting | Badalona | Barcelona | 08916 | Spain |
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| Sham tRNS | Other | 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 . |
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| 1 day |
| Wisconsin Card Sorting Test (WCST) | To improve performance in set-shifting | 1 day |
| Stroop Color and Word test (Stroop Test) | To improve performance in inhibitory control | 1 day |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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