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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06228872
Other study ID # Resolution number 340
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 5, 2024
Est. completion date June 1, 2025

Study information

Verified date January 2024
Source Mutual de Seguridad Hospital Clinico
Contact Lucia E Del Valle Batalla, MD
Phone +56981486933
Email luciadelvalle@ug.uchile.cl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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). 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 38
Est. completion date June 1, 2025
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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.

Study Design


Intervention

Device:
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
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

Locations

Country Name City State
Chile Hospital de Mutual de Seguridad Santiago Metropolitan Region

Sponsors (1)

Lead Sponsor Collaborator
Mutual de Seguridad Hospital Clinico

Country where clinical trial is conducted

Chile, 

References & Publications (25)

Bolognini 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. — View Citation

Capizzi A, Woo J, Verduzco-Gutierrez M. Traumatic Brain Injury: An Overview of Epidemiology, Pathophysiology, and Medical Management. Med Clin North Am. 2020 Mar;104(2):213-238. doi: 10.1016/j.mcna.2019.11.001. — View Citation

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. — View Citation

Demirtas-Tatlidede A, Vahabzadeh-Hagh AM, Bernabeu M, Tormos JM, Pascual-Leone A. Noninvasive brain stimulation in traumatic brain injury. J Head Trauma Rehabil. 2012 Jul-Aug;27(4):274-92. doi: 10.1097/HTR.0b013e318217df55. — View Citation

Dikmen 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. — View Citation

Eilam-Stock T, George A, Charvet LE. Cognitive Telerehabilitation with Transcranial Direct Current Stimulation Improves Cognitive and Emotional Functioning Following a Traumatic Brain Injury: A Case Study. Arch Clin Neuropsychol. 2021 Apr 21;36(3):442-453. doi: 10.1093/arclin/acaa059. — View Citation

Elsner 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. — View Citation

Fawcett J. Molecular control of brain plasticity and repair. Prog Brain Res. 2009;175:501-9. doi: 10.1016/S0079-6123(09)17534-9. — View Citation

Fernandez 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. — View Citation

Hyder AA, Wunderlich CA, Puvanachandra P, Gururaj G, Kobusingye OC. The impact of traumatic brain injuries: a global perspective. NeuroRehabilitation. 2007;22(5):341-53. — View Citation

Jaeggi 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. — View Citation

Jak 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. — View Citation

Kang 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. — View Citation

Kueider 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. — View Citation

Lesniak 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. — View Citation

Li S, Zaninotto AL, Neville IS, Paiva WS, Nunn D, Fregni F. Clinical utility of brain stimulation modalities following traumatic brain injury: current evidence. Neuropsychiatr Dis Treat. 2015 Jun 30;11:1573-86. doi: 10.2147/NDT.S65816. eCollection 2015. — View Citation

McInnes K, Friesen CL, MacKenzie DE, Westwood DA, Boe SG. Mild Traumatic Brain Injury (mTBI) and chronic cognitive impairment: A scoping review. PLoS One. 2017 Apr 11;12(4):e0174847. doi: 10.1371/journal.pone.0174847. eCollection 2017. Erratum In: PLoS One. 2019 Jun 11;14(6):e0218423. — View Citation

Motes MA, Spence JS, Yeatman K, Jones PM, Lutrell M, O'Hair R, Shakal S, DeLaRosa BL, To W, Vanneste S, Kraut MA, Hart J , Jr. High-Definition Transcranial Direct Current Stimulation to Improve Verbal Retrieval Deficits in Chronic Traumatic Brain Injury. J Neurotrauma. 2020 Jan 1;37(1):170-177. doi: 10.1089/neu.2018.6331. Epub 2019 Sep 3. — View Citation

Quinn DK, Upston J, Jones T, Brandt E, Story-Remer J, Fratzke V, Wilson JK, Rieger R, Hunter MA, Gill D, Richardson JD, Campbell R, Clark VP, Yeo RA, Shuttleworth CW, Mayer AR. Cerebral Perfusion Effects of Cognitive Training and Transcranial Direct Current Stimulation in Mild-Moderate TBI. Front Neurol. 2020 Oct 7;11:545174. doi: 10.3389/fneur.2020.545174. eCollection 2020. — View Citation

Russo 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. — View Citation

Sacco K, Galetto V, Dimitri D, Geda E, Perotti F, Zettin M, Geminiani GC. Concomitant Use of Transcranial Direct Current Stimulation and Computer-Assisted Training for the Rehabilitation of Attention in Traumatic Brain Injured Patients: Behavioral and Neuroimaging Results. Front Behav Neurosci. 2016 Mar 31;10:57. doi: 10.3389/fnbeh.2016.00057. eCollection 2016. — View Citation

Sozda 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. — View Citation

Stagg 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. — View Citation

Ulam F, Shelton C, Richards L, Davis L, Hunter B, Fregni F, Higgins K. Cumulative effects of transcranial direct current stimulation on EEG oscillations and attention/working memory during subacute neurorehabilitation of traumatic brain injury. Clin Neurophysiol. 2015 Mar;126(3):486-96. doi: 10.1016/j.clinph.2014.05.015. Epub 2014 Jun 2. — View Citation

Veerbeek 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. — View Citation

* Note: There are 25 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary Executive Cognitive function (Working Memory) Measurement of working memory using Digit Span forward and backward. Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Primary Executive Cognitive Function Assessment of general executive cognitive function using Ineco Frontal Screening (IFS) evaluation. Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Secondary Mood Assessment of mood using the Structured Clinical Interview for Depression (SCID) to detect depressive symptoms. Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
Secondary 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. Baseline (T0), immediate post-treatment (T1), and one month post-treatment (T2).
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