Traumatic Brain InjurytDCS-TECNCT06228872
"Cognitive Rehabilitation With Direct Current Transcranial Stimulation in Post-Traumatic Brain Injury Patients"
A study testing Cognitive Computerized Training (CCT) plus Anodic transcranial Direct Current Stimulation (tDCS) in people with Traumatic Brain Injury and Cognitive Impairment, run by Mutual de Seguridad Hospital Clinico at 1 site in Chile.
Trial summary
The goal of this clinical trial is to investigate the impact of daily self-administered transcranial direct current stimulation (tDCS) therapy on the cognitive function of individuals with moderate to severe cognitive impairment resulting from a traumatic brain injury (TBI). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Traumatic Brain Injury, Cognitive Impairment
- What is being tested?
- Cognitive Computerized Training (CCT) plus Anodic transcranial Direct Current Stimulation (tDCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 1 siteChile
- Study dates
- 5 Jan 2024to 1 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-65 years.
- Moderate to severe traumatic brain injury (TBI) according to classification 58 (see Table 3) with a duration of 6 to 12 months.
- Minimum of 8 years of education (completed basic education with literacy skills).
- Meeting diagnostic criteria (see Table 3) for mild or major cognitive impairment according to the Diagnostic and Statistical Manual of Mental Disorders (DSM).
- Capacity to make decisions and understand relevant information regarding participation in a clinical trial, assessed using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) 60.
- Inclusion of patients with chronic TBI (defined for this study as more than 6 months of duration) based on the proposed mechanism of chronic TBI involving decreased cerebral neuroplasticity, leading to long-term cognitive dysfunction and functional limitations 62. Transcranial Direct Current Stimulation (tDCS) has shown effectiveness in enhancing neuroplasticity in various neurological and psychiatric conditions 63.
Who cannot join
- History of cognitive impairment unrelated to post-traumatic causes (for which the patient is being treated at Mutual de Seguridad).
- History of epileptic seizures.
- Pre-existing neuropsychiatric disorders.
- Presence of metallic objects in the body such as aneurysm implants, hemostatic clips, implanted electrodes, and electrical devices like pacemakers.
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Hospital de Mutual de Seguridad
Santiago, Metropolitan Region
Cristian Y Melian, MD, +56994527972, cotomelian@gmail.com
Lucia E Del Valle Batalla, MD
About this study
Official title: Direct Current Transcranial Stimulation as Cognitive Rehabilitation Therapy in Post-Traumatic Brain Injury Patients.
The goal of this clinical trial is to investigate the impact of daily self-administered transcranial direct current stimulation (tDCS) therapy on the cognitive function of individuals with moderate to severe cognitive impairment resulting from a traumatic brain injury (TBI). The study aims to answer the following questions:
Does daily self-administered tDCS therapy, when combined with computerized cognitive training (CCT), improve cognitive function in TBI patients? Is CCT+tDCS with anodic stimulation more effective than CCT+tDCS with simulated stimulation in enhancing immediate and one-month post-treatment cognitive function? Does CCT+tDCS with anodic stimulation lead to better functionality immediately and one month after treatment compared to CCT+tDCS with simulated stimulation? Does CCT+tDCS with anodic stimulation have a positive impact on mood improvement immediately and one month after treatment compared to CCT+tDCS with simulated stimulation? Participants in the study will engage in CCT through a smartphone or tablet application and self-administer tDCS therapy for 20 minutes each day for a duration of one month. The tDCS therapy will involve applying a 2 mA anodic current to the prefrontal dorsolateral cortex (PFDL). Prior to the intervention, patients or their caregivers will receive training on the proper and safe usage of the tDCS device. Cognitive function, mood, and functionality will be evaluated before and after the intervention using appropriate measurement scales.
The outcomes of this clinical trial have the potential to identify an effective and accessible therapeutic approach to enhance cognitive function in individuals with moderate to severe TBI. The combination of tDCS therapy with CCT offers an appealing and feasible treatment strategy for these patients, particularly when conducted in a home setting. The findings from this study will guide future clinical trials in the field of cognitive rehabilitation for TBI patients. Researchers will compare active tDCS with sham tDCS to determine if there are differences in the primary outcomes mentioned.
Read the detailed description
Introduction: Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that can modulate neuronal excitability and enhance neuroplasticity. On the other hand, computerized cognitive training (CCT) therapy uses computers to improve cognitive domains through repeated practice of theoretically-driven skills and strategies. So far, the isolated use of tDCS and its combination with CCT have been explored in the cognitive recovery of patients with traumatic brain injury (TBI), yielding promising results. However, none of the studies to date have investigated the use of a self-administered therapy (by the patient and/or caregiver) that combines both interventions at home. The objective of this clinical trial is to evaluate the effect of daily self-administered tDCS therapy on cognitive function in patients with moderate-to-severe TBI-associated cognitive impairment.
Methodology: A prospective, controlled, double-blind, randomized clinical trial is proposed. The intervention will consist of (i) CCT delivered through a smartphone or tablet application and (ii) the application of 2 mA tDCS therapy (20 minutes of anodic current for the experimental group and 60 seconds for the control group) to the prefrontal dorsolateral cortex (PFDL) daily for one month, self-administered by the patient. Prior to the intervention, a training session will be conducted to instruct the patient (or caregiver) on the correct and safe use of the device. The primary outcomes will be cognitive function, mood, and functionality, measured before and after the intervention using appropriate scales.
Discussion: The results of this clinical trial could contribute to the identification of an effective and accessible therapeutic method to improve cognitive function in patients with moderate-to-severe TBI. The combination of tDCS therapy with CCT may offer an attractive and feasible therapeutic strategy for these patients, particularly when performed at home. The findings of this study may be useful in guiding future clinical trials in the field of cognitive rehabilitation in TBI patients.
- Conditions
- Traumatic Brain Injury, Cognitive Impairment
- Being tested
- Cognitive Computerized Training (CCT) plus Anodic transcranial Direct Current Stimulation (tDCS), Cognitive Computerized Training (CCT) plus sham transcranial Direct Current Stimulation (tDCS)
- Keywords
- Transcranial direct current stimulation (tDCS), Computerized cognitive training (CCT), Traumatic brain injury (TBI), Cognitive Impairment
- Medical subject headings
- Brain Injuries, Traumatic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Computerized Training (CCT) plus Anodic transcranial Direct Current Stimulation (tDCS)Device
Computerized Cognitive Training (15 min) + Anodal tDCS over DLPFC (20 min) daily for 1 month
Cognitive Computerized Training (CCT) plus sham transcranial Direct Current Stimulation (tDCS)Device
Computerized Cognitive Training (15 min) + Sham tDCS over DLPFC (20 min) daily for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Participants will receive Computerized Cognitive Training and anodal tDCS daily for one month. Stimulation will consist of 20 min of anodal 2mA tDCS stimulation over the DLPFC, followed by 15 min of computerized cognitive training. Receives: Device: Cognitive Computerized Training (CCT) plus Anodic transcranial Direct Current Stimulation (tDCS) |
| Control Group | Sham comparator | Participants will receive Computerized Cognitive Training and sham tDCS daily for one month. Sham stimulation will consist of 60 seconds of anodal 2mA tDCS stimulation over the DLPFC, followed by 19 mins of no current delivery. The same 15 min of computerized cognitive training will be provided after the end of the Sham Stimulation. Receives: Device: Cognitive Computerized Training (CCT) plus sham transcranial Direct Current Stimulation (tDCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive Cognitive function (Working Memory)
Measurement of working memory using Digit Span forward and backward.
Measured: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Executive Cognitive Function
Assessment of general executive cognitive function using Ineco Frontal Screening (IFS) evaluation.
Measured: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Secondary outcomes (2)
Mood
Assessment of mood using the Structured Clinical Interview for Depression (SCID) to detect depressive symptoms.
Measured: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Functional Independence
Evaluation of functional independence using the Functional Independence Measure (FIM) associated with the Functional Assessment Measure (FAM). FIM assesses independence in various domains of activities of daily living, while FAM is used to measure functionality and performance in daily activities.
Measured: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start5 Jan 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a prospective, controlled, double-blind, randomized clinical trial in collaboration with the University of Chile. It includes patients with moderate cognitive impairment due to moderate-to-severe traumatic brain injury lasting over 6 months. Participants will be randomly assigned to the experimental or control group. The intervention involves computerized cognitive training (CCT) through a mobile app and daily self-administered transcranial direct current stimulation (tDCS) therapy to the prefrontal dorsolateral cortex (PFDL) for one month. Prior to the intervention, a training session will instruct patients on device use and adverse effects monitoring. Neuropsychological evaluations will be conducted at baseline (T0), immediately after the last session (T1), and one month later (T2). This trial aims to assess the efficacy of combined CCT and tDCS for cognitive impairment in TBI patients.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 38 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mutual de Seguridad Hospital Clinico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose M Matamala Capponi, MD, Principal investigator, Associated Professor of the University of Chile
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06228872
- Sponsor's protocol ID
- Resolution number 340
- Acronym
- tDCS-TEC
- Status last verified
- Jan 2024
- First submitted
- 6 Jul 2023
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deidda G, Bozarth IF, Cancedda L. Modulation of GABAergic transmission in development and neurodevelopmental disorders: investigating physiology and pathology to gain therapeutic perspectives. Front Cell Neurosci. 2014 May 22;8:119. doi: 10.3389/fncel.2014.00119. eCollection 2014.
PubMed 24904277Fernandez E, Bringas ML, Salazar S, Rodriguez D, Garcia ME, Torres M. Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. MEDICC Rev. 2012 Oct;14(4):32-5. doi: 10.37757/MR2012V14.N4.8.
PubMed 23154316Kang EK, Kim DY, Paik NJ. Transcranial direct current stimulation of the left prefrontal cortex improves attention in patients with traumatic brain injury: a pilot study. J Rehabil Med. 2012 Apr;44(4):346-50. doi: 10.2340/16501977-0947.
PubMed 22434324Hyder AA, Wunderlich CA, Puvanachandra P, Gururaj G, Kobusingye OC. The impact of traumatic brain injuries: a global perspective. NeuroRehabilitation. 2007;22(5):341-53.
PubMed 18162698Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
PubMed 33175411Dikmen S, Machamer J, Fann JR, Temkin NR. Rates of symptom reporting following traumatic brain injury. J Int Neuropsychol Soc. 2010 May;16(3):401-11. doi: 10.1017/S1355617710000196. Epub 2010 Mar 1.
PubMed 20188017Jaeggi SM, Seewer R, Nirkko AC, Eckstein D, Schroth G, Groner R, Gutbrod K. Does excessive memory load attenuate activation in the prefrontal cortex? Load-dependent processing in single and dual tasks: functional magnetic resonance imaging study. Neuroimage. 2003 Jun;19(2 Pt 1):210-25. doi: 10.1016/s1053-8119(03)00098-3.
PubMed 12814572Bolognini N, Pascual-Leone A, Fregni F. Using non-invasive brain stimulation to augment motor training-induced plasticity. J Neuroeng Rehabil. 2009 Mar 17;6:8. doi: 10.1186/1743-0003-6-8.
PubMed 19292910Lesniak M, Polanowska K, Seniow J, Czlonkowska A. Effects of repeated anodal tDCS coupled with cognitive training for patients with severe traumatic brain injury: a pilot randomized controlled trial. J Head Trauma Rehabil. 2014 May-Jun;29(3):E20-9. doi: 10.1097/HTR.0b013e318292a4c2.
PubMed 23756431Sozda CN, Muir JJ, Springer US, Partovi D, Cole MA. Differential learning and memory performance in OEF/OIF veterans for verbal and visual material. Neuropsychology. 2014 May;28(3):347-352. doi: 10.1037/neu0000043. Epub 2013 Nov 18.
PubMed 24245926Stagg CJ, Best JG, Stephenson MC, O'Shea J, Wylezinska M, Kincses ZT, Morris PG, Matthews PM, Johansen-Berg H. Polarity-sensitive modulation of cortical neurotransmitters by transcranial stimulation. J Neurosci. 2009 Apr 22;29(16):5202-6. doi: 10.1523/JNEUROSCI.4432-08.2009.
PubMed 19386916Jak AJ, Seelye AM, Jurick SM. Crosswords to computers: a critical review of popular approaches to cognitive enhancement. Neuropsychol Rev. 2013 Mar;23(1):13-26. doi: 10.1007/s11065-013-9226-5. Epub 2013 Feb 20.
PubMed 23423553Kueider AM, Parisi JM, Gross AL, Rebok GW. Computerized cognitive training with older adults: a systematic review. PLoS One. 2012;7(7):e40588. doi: 10.1371/journal.pone.0040588. Epub 2012 Jul 11.
PubMed 22792378Veerbeek JM, van Wegen E, van Peppen R, van der Wees PJ, Hendriks E, Rietberg M, Kwakkel G. What is the evidence for physical therapy poststroke? A systematic review and meta-analysis. PLoS One. 2014 Feb 4;9(2):e87987. doi: 10.1371/journal.pone.0087987. eCollection 2014.
PubMed 24505342Russo C, Souza Carneiro MI, Bolognini N, Fregni F. Safety Review of Transcranial Direct Current Stimulation in Stroke. Neuromodulation. 2017 Apr;20(3):215-222. doi: 10.1111/ner.12574. Epub 2017 Feb 21.
PubMed 28220641
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct Current Transcranial Stimulation as Cognitive Rehabilitation Therapy in Post-Traumatic Brain Injury Patients.
- ClinicalTrials.gov ID
- NCT06228872
- Acronym / sponsor ID
- tDCS-TEC / Resolution number 340
- Conditions
- Traumatic Brain Injury, Cognitive Impairment
- Keywords
- Transcranial direct current stimulation (tDCS), Computerized cognitive training (CCT), Traumatic brain injury (TBI), Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 38 participants (estimated)
- Lead sponsor
- Mutual de Seguridad Hospital ClinicoUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 29 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to investigate the impact of daily self-administered transcranial direct current stimulation (tDCS) therapy on the cognitive function of individuals with moderate to severe cognitive impairment resulting from a traumatic brain injury (TBI). The study aims to answer the following questions:
Does daily self-administered tDCS therapy, when combined with computerized cognitive training (CCT), improve cognitive function in TBI patients? Is CCT+tDCS with anodic stimulation more effective than CCT+tDCS with simulated stimulation in enhancing immediate and one-month post-treatment cognitive function? Does CCT+tDCS with anodic stimulation lead to better functionality immediately and one month after treatment compared to CCT+tDCS with simulated stimulation? Does CCT+tDCS with anodic stimulation have a positive impact on mood improvement immediately and one month after treatment compared to CCT+tDCS with simulated stimulation? Participants in the study will engage in CCT through a smartphone or tablet application and self-administer tDCS therapy for 20 minutes each day for a duration of one month. The tDCS therapy will involve applying a 2 mA anodic current to the prefrontal dorsolateral cortex (PFDL). Prior to the intervention, patients or their caregivers will receive training on the proper and safe usage of the tDCS device. Cognitive function, mood, and functionality will be evaluated before and after the intervention using appropriate measurement scales.
The outcomes of this clinical trial have the potential to identify an effective and accessible therapeutic approach to enhance cognitive function in individuals with moderate to severe TBI. The combination of tDCS therapy with CCT offers an appealing and feasible treatment strategy for these patients, particularly when conducted in a home setting. The findings from this study will guide future clinical trials in the field of cognitive rehabilitation for TBI patients. Researchers will compare active tDCS with sham tDCS to determine if there are differences in the primary outcomes mentioned.
Detailed description
Introduction: Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that can modulate neuronal excitability and enhance neuroplasticity. On the other hand, computerized cognitive training (CCT) therapy uses computers to improve cognitive domains through repeated practice of theoretically-driven skills and strategies. So far, the isolated use of tDCS and its combination with CCT have been explored in the cognitive recovery of patients with traumatic brain injury (TBI), yielding promising results. However, none of the studies to date have investigated the use of a self-administered therapy (by the patient and/or caregiver) that combines both interventions at home. The objective of this clinical trial is to evaluate the effect of daily self-administered tDCS therapy on cognitive function in patients with moderate-to-severe TBI-associated cognitive impairment.
Methodology: A prospective, controlled, double-blind, randomized clinical trial is proposed. The intervention will consist of (i) CCT delivered through a smartphone or tablet application and (ii) the application of 2 mA tDCS therapy (20 minutes of anodic current for the experimental group and 60 seconds for the control group) to the prefrontal dorsolateral cortex (PFDL) daily for one month, self-administered by the patient. Prior to the intervention, a training session will be conducted to instruct the patient (or caregiver) on the correct and safe use of the device. The primary outcomes will be cognitive function, mood, and functionality, measured before and after the intervention using appropriate scales.
Discussion: The results of this clinical trial could contribute to the identification of an effective and accessible therapeutic method to improve cognitive function in patients with moderate-to-severe TBI. The combination of tDCS therapy with CCT may offer an attractive and feasible therapeutic strategy for these patients, particularly when performed at home. The findings of this study may be useful in guiding future clinical trials in the field of cognitive rehabilitation in TBI patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a prospective, controlled, double-blind, randomized clinical trial in collaboration with the University of Chile. It includes patients with moderate cognitive impairment due to moderate-to-severe traumatic brain injury lasting over 6 months. Participants will be randomly assigned to the experimental or control group. The intervention involves computerized cognitive training (CCT) through a mobile app and daily self-administered transcranial direct current stimulation (tDCS) therapy to the prefrontal dorsolateral cortex (PFDL) for one month. Prior to the intervention, a training session will instruct patients on device use and adverse effects monitoring. Neuropsychological evaluations will be conducted at baseline (T0), immediately after the last session (T1), and one month later (T2). This trial aims to assess the efficacy of combined CCT and tDCS for cognitive impairment in TBI patients.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Cognitive Computerized Training (CCT) plus Anodic transcranial Direct Current Stimulation (tDCS)Participants will receive Computerized Cognitive Training and anodal tDCS daily for one month. Stimulation will consist of 20 min of anodal 2mA tDCS stimulation over the DLPFC, followed by 15 min of computerized cognitive training. |
| Control Group | Sham comparator | Device: Cognitive Computerized Training (CCT) plus sham transcranial Direct Current Stimulation (tDCS)Participants will receive Computerized Cognitive Training and sham tDCS daily for one month. Sham stimulation will consist of 60 seconds of anodal 2mA tDCS stimulation over the DLPFC, followed by 19 mins of no current delivery. The same 15 min of computerized cognitive training will be provided after the end of the Sham Stimulation. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18-65 years.
- Moderate to severe traumatic brain injury (TBI) according to classification 58 (see Table 3) with a duration of 6 to 12 months.
- Minimum of 8 years of education (completed basic education with literacy skills).
- Meeting diagnostic criteria (see Table 3) for mild or major cognitive impairment according to the Diagnostic and Statistical Manual of Mental Disorders (DSM).
- Capacity to make decisions and understand relevant information regarding participation in a clinical trial, assessed using the MacArthur Competence Assessment Tool for Clinical Research (MacCAT-CR) 60.
Key exclusion criteria (4 listed)
- History of cognitive impairment unrelated to post-traumatic causes (for which the patient is being treated at Mutual de Seguridad).
- History of epileptic seizures.
- Pre-existing neuropsychiatric disorders.
- Presence of metallic objects in the body such as aneurysm implants, hemostatic clips, implanted electrodes, and electrical devices like pacemakers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Computerized Training (CCT) plus Anodic transcranial Direct Current Stimulation (tDCS)Computerized Cognitive Training (15 min) + Anodal tDCS over DLPFC (20 min) daily for 1 month | Device | Experimental Group |
| Cognitive Computerized Training (CCT) plus sham transcranial Direct Current Stimulation (tDCS)Computerized Cognitive Training (15 min) + Sham tDCS over DLPFC (20 min) daily for 1 month | Device | Control Group |
Primary outcome
Executive Cognitive function (Working Memory)
Time frame: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Measurement of working memory using Digit Span forward and backward.
Executive Cognitive Function
Time frame: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Assessment of general executive cognitive function using Ineco Frontal Screening (IFS) evaluation.
2 secondary outcomes
Mood
Time frame: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Functional Independence
Time frame: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Background: PubMed 24904277Deidda G, Bozarth IF, Cancedda L. Modulation of GABAergic transmission in development and neurodevelopmental disorders: investigating physiology and pathology to gain therapeutic perspectives. Front Cell Neurosci. 2014 May 22;8:119. doi: 10.3389/fncel.2014.00119. eCollection 2014.
- Background: PubMed 23154316Fernandez E, Bringas ML, Salazar S, Rodriguez D, Garcia ME, Torres M. Clinical impact of RehaCom software for cognitive rehabilitation of patients with acquired brain injury. MEDICC Rev. 2012 Oct;14(4):32-5. doi: 10.37757/MR2012V14.N4.8.
- Background: PubMed 22434324Kang EK, Kim DY, Paik NJ. Transcranial direct current stimulation of the left prefrontal cortex improves attention in patients with traumatic brain injury: a pilot study. J Rehabil Med. 2012 Apr;44(4):346-50. doi: 10.2340/16501977-0947.
- Background: PubMed 18162698Hyder AA, Wunderlich CA, Puvanachandra P, Gururaj G, Kobusingye OC. The impact of traumatic brain injuries: a global perspective. NeuroRehabilitation. 2007;22(5):341-53.
- Background: PubMed 33175411Elsner B, Kugler J, Pohl M, Mehrholz J. Transcranial direct current stimulation (tDCS) for improving activities of daily living, and physical and cognitive functioning, in people after stroke. Cochrane Database Syst Rev. 2020 Nov 11;11(11):CD009645. doi: 10.1002/14651858.CD009645.pub4.
- Background: PubMed 20188017Dikmen S, Machamer J, Fann JR, Temkin NR. Rates of symptom reporting following traumatic brain injury. J Int Neuropsychol Soc. 2010 May;16(3):401-11. doi: 10.1017/S1355617710000196. Epub 2010 Mar 1.
- Background: PubMed 12814572Jaeggi SM, Seewer R, Nirkko AC, Eckstein D, Schroth G, Groner R, Gutbrod K. Does excessive memory load attenuate activation in the prefrontal cortex? Load-dependent processing in single and dual tasks: functional magnetic resonance imaging study. Neuroimage. 2003 Jun;19(2 Pt 1):210-25. doi: 10.1016/s1053-8119(03)00098-3.
- Background: PubMed 19292910Bolognini N, Pascual-Leone A, Fregni F. Using non-invasive brain stimulation to augment motor training-induced plasticity. J Neuroeng Rehabil. 2009 Mar 17;6:8. doi: 10.1186/1743-0003-6-8.
- Background: PubMed 23756431Lesniak M, Polanowska K, Seniow J, Czlonkowska A. Effects of repeated anodal tDCS coupled with cognitive training for patients with severe traumatic brain injury: a pilot randomized controlled trial. J Head Trauma Rehabil. 2014 May-Jun;29(3):E20-9. doi: 10.1097/HTR.0b013e318292a4c2.
- Background: PubMed 24245926Sozda CN, Muir JJ, Springer US, Partovi D, Cole MA. Differential learning and memory performance in OEF/OIF veterans for verbal and visual material. Neuropsychology. 2014 May;28(3):347-352. doi: 10.1037/neu0000043. Epub 2013 Nov 18.
- Background: PubMed 19386916Stagg CJ, Best JG, Stephenson MC, O'Shea J, Wylezinska M, Kincses ZT, Morris PG, Matthews PM, Johansen-Berg H. Polarity-sensitive modulation of cortical neurotransmitters by transcranial stimulation. J Neurosci. 2009 Apr 22;29(16):5202-6. doi: 10.1523/JNEUROSCI.4432-08.2009.
- Background: PubMed 23423553Jak AJ, Seelye AM, Jurick SM. Crosswords to computers: a critical review of popular approaches to cognitive enhancement. Neuropsychol Rev. 2013 Mar;23(1):13-26. doi: 10.1007/s11065-013-9226-5. Epub 2013 Feb 20.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose M Matamala Capponi, MD principal investigator
Associated Professor of the University of Chile
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Computerized Training (CCT) plus Anodic transcranial Direct Current Stimulation (tDCS) in people with Traumatic Brain Injury and Cognitive Impairment, run by Mutual de Seguridad Hospital Clinico at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lucia E Del Valle Batalla, MD (+56981486933, luciadelvalle@ug.uchile.cl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Executive Cognitive function (Working Memory) (time frame: Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06228872, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.