Traumatic Brain InjuryNCT06149975
Feasibility of a Motor-cognitive Training Program in Patients With Traumatic Brain Injury
A study testing motor-cognitive training in people with Traumatic Brain Injury, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
Trial summary
The goal of this clinical study is to test feasibility of a motor-cognitive training program in patients after mild to severe traumatic brain injury in an acute hospitalization setting. The intervention is a step-based dual-task training, i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- motor-cognitive training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Nov 2023to 13 Jun 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- People diagnosed with mild (Glasgow Coma Scale 14-15), moderate (Glasgow Coma Scale 9-13) or severe (Glasgow Coma Scale 3-8) TBI
- Age ≥ 18 years
- Planned hospital treatment >24h on regular ward (non-ICU)
- Physically able to stand (using cane if needed)
- Able to give informed consent
Who cannot join
- Limited vision and hearing ability (except facial injuries with monocular swelling)
- Inability or contraindications to undergo the investigated intervention.
- ICU stay only
- Montreal Cognitive Assessment (MoCa) score < 16
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of a Motor-cognitive Training Program in Patients With Traumatic Brain Injury During Acute Hospitalization
The goal of this clinical study is to test feasibility of a motor-cognitive training program in patients after mild to severe traumatic brain injury in an acute hospitalization setting.
The intervention is a step-based dual-task training, i.e. patients are presented with step patterns that they have to memorize and then execute in the tempo given by a metronome.
Researchers will assess the feasibility of the motor-cognitive training regarding acceptance and safety, user evaluation of the training and training performance.
Read the detailed description
A traumatic brain injury (TBI) refers to a functional disorder of the brain with or without demonstrable injuries to the brain as a result of external force to the skull and/or brain. The most common causes are traffic accidents and falls. After TBI, impairments may occur in motor skills such as gait stability, static and dynamic balance and motor coordination as well as cognitive skills such as memory, dual- and multi-tasking (DT/MT), and psychomotor speed. Therefore, rapid improvement of motor and cognitive functioning and falls prevention are essential.
Dual-task training have been shown to improve gait performance and to reduce the risk of falling in some neurological disorders, such as Parkinson's disease and stroke. Although there are differences in the underlying pathophysiology between these neurological conditions and TBI, research has identified many common fall-risk factors and thus it can be expected that TBI patients would also profit from cognitive-motor dual-task training. However, research on the effects of such training in TBI patients in scarce. To our knowledge, there is only one study that has looked into the effects of dual-task motor-cognitive training in people with neurological conditions, including (but not specifically for) persons with TBI. For this reason, this study aims to assess the feasibility of a concept for stepping training (StepIt) that addresses motor as well as cognitive falls-related aspects in patients with TBI.
This study will be conducted as one-arm, monocentric intervention trial. After admission to the normal ward, patients potentially fulfilling the eligibility criteria will be informed orally and in writing about the study and asked if they wish to participate. All interested participants will then be screened for final inclusion. Baseline data collection will occur prior to the first training session and training evaluation will be conducted after 3 to max. 10 trainings (depending on the length of their hospital stay). During each training session individual training parameters will be documented. In addition to the usual care, the study participants receive the motor-cognitive training "StepIt". The "StepIt" will be conducted as an approximately 15-minute one on one training for at least 3 to max. 10 sessions during the stay at the hospital.
- Conditions
- Traumatic Brain Injury
- Being tested
- motor-cognitive training
- Keywords
- motor-cognitive training, dual-task, TBI
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
motor-cognitive trainingOther
The motor-cognitive training in this study will be conducted in form of a step-based dual-task training. A mat (approximately 90 x 90 cm) made from extra non-slip yoga mats is required. The mat is divided into 9 equal squares with a 3 x 3 pattern. Participants will be presented with stepping patterns which they must memorize and then execute on the mat in the pace given by a metronome. All participants will start at the same level. The progression will be adjusted individually according to the fixed criteria of the "StepIt" concept within the sessions. All sessions will be supervised by at least one physical therapist.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | In addition to the usual care, the study participants receive the motor-cognitive training "StepIt". The "StepIt" will be conducted as an approximately 15-minute one on one training for at least 3 to max. 10 sessions during the stay at the hospital. Receives: Other: motor-cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Number of patients fitting to the inclusion exclusion (resp. exclusion) criteria as percentages of persons with TBI admitted in the hospital during the study period
Measured: through study completion, an average of 9 months
Inclusion rate
Number of patients included in the study as percentages of patients fitting to the inclusion (resp. exclusion) criteria
Measured: through study completion, an average of 9 months
Attrition rate
Number of Drop-outs as percentages of patients included in the study
Measured: through study completion, an average of 9 months
Adherence rate
Number of attended training sessions as percentages of total possible training sessions
Measured: through study completion, an average of 9 months (over all training sessions)
Compliance rate
Number of attended training minutes as percentages of the total possible training minutes
Measured: through study completion, an average of 9 months (over all training sessions)
Security incidents
Total number of (Serious) Adverse Events (SAE/AE)
Measured: through study completion, an average of 9 months (over all training sessions)
Secondary outcomes (4)
Physical and cognitive load
Physical and cognitive load assessed with the National Aeronautics and Space Administration-Task Load Index (NASA-TLX). The NASA-TLX is a self-report, multidimensional assessment tool that rates perceived workload in order to assess a task, a system, or other aspects of performance (in this case the "StepIi" trainings). It contains five subscales: Mental Demand, Physical Demand, Temporal Demand, Performance, Effort and Frustration. Each subscale can be given a score between 0 and 20. A higher score reflects a higher workload.
Measured: through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
Patient Satisfaction
With a tailored (self-made) usability questionnaire the patient satisfaction will be assessed. The questionnaire records how the participants felt about the training, how satisfied they were with the training and whether they would recommend the training to others. The questionnaire contains 13 questions (Yes-No questions, Likert-Scale, and open questions). Each item will be evaluated separately.
Measured: through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
Improvement
Comparison of the entry level versus the highest achieved level in percentage (for following training parameters: i. length of stepping sequence, ii.beats/minute, iii. Stepping sequence complexity)
Measured: through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
Training capacity
Number of taught patterns per training session
Measured: through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start20 Nov 2023
- Primary completion13 Jun 2024
- Study completion13 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Federal Institute of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen
- Responsible party
- Principal investigator, Eleftheria Giannouli, Swiss Federal Institute of Technology
- Investigators
- Anne-Katrin Hickmann, PD Dr., Study director, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149975
- Sponsor's protocol ID
- StepIt TBI
- Status last verified
- Jul 2024
- First submitted
- 22 Oct 2023
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Menon DK, Schwab K, Wright DW, Maas AI; Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health. Position statement: definition of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1637-40. doi: 10.1016/j.apmr.2010.05.017.
PubMed 21044706Brazinova A, Rehorcikova V, Taylor MS, Buckova V, Majdan M, Psota M, Peeters W, Feigin V, Theadom A, Holkovic L, Synnot A. Epidemiology of Traumatic Brain Injury in Europe: A Living Systematic Review. J Neurotrauma. 2021 May 15;38(10):1411-1440. doi: 10.1089/neu.2015.4126. Epub 2018 Dec 19.
PubMed 26537996Galea OA, Cottrell MA, Treleaven JM, O'Leary SP. Sensorimotor and Physiological Indicators of Impairment in Mild Traumatic Brain Injury: A Meta-Analysis. Neurorehabil Neural Repair. 2018 Feb;32(2):115-128. doi: 10.1177/1545968318760728.
PubMed 29554850Rabinowitz AR, Levin HS. Cognitive sequelae of traumatic brain injury. Psychiatr Clin North Am. 2014 Mar;37(1):1-11. doi: 10.1016/j.psc.2013.11.004. Epub 2014 Jan 14.
PubMed 24529420Berkner J, Meehan WP 3rd, Master CL, Howell DR. Gait and Quiet-Stance Performance Among Adolescents After Concussion-Symptom Resolution. J Athl Train. 2017 Dec;52(12):1089-1095. doi: 10.4085/1062-6050-52.11.23. Epub 2017 Nov 20.
PubMed 29154694Spano B, De Tollis M, Taglieri S, Manzo A, Ricci C, Lombardi MG, Polidori L, Griffini IA, Aloisi M, Vinicola V, Formisano R, Caltagirone C, Annicchiarico R. The Effect of Dual-Task Motor-Cognitive Training in Adults with Neurological Diseases Who Are at Risk of Falling. Brain Sci. 2022 Sep 7;12(9):1207. doi: 10.3390/brainsci12091207.
PubMed 36138943Giannouli E, Morat T, Zijlstra W. A Novel Square-Stepping Exercise Program for Older Adults (StepIt): Rationale and Implications for Falls Prevention. Front Med (Lausanne). 2020 Jan 14;6:318. doi: 10.3389/fmed.2019.00318. eCollection 2019.
PubMed 31993435Fritz NE, Basso DM. Dual-task training for balance and mobility in a person with severe traumatic brain injury: a case study. J Neurol Phys Ther. 2013 Mar;37(1):37-43. doi: 10.1097/NPT.0b013e318282a20d.
PubMed 23364169Zhou Q, Yang H, Zhou Q, Pan H. Effects of cognitive motor dual-task training on stroke patients: A RCT-based meta-analysis. J Clin Neurosci. 2021 Oct;92:175-182. doi: 10.1016/j.jocn.2021.08.009. Epub 2021 Aug 25.
PubMed 34509248Silva RDN, Afonso SV, Felipe LR, Oliveira RA, Patrizzi Martins LJ, Pascucci Sande de Souza LA. Dual-task intervention based on trail making test: Effects on Parkinson's disease. J Bodyw Mov Ther. 2021 Jul;27:628-633. doi: 10.1016/j.jbmt.2021.04.013. Epub 2021 May 4.
PubMed 34391298Yang YR, Chen YC, Lee CS, Cheng SJ, Wang RY. Dual-task-related gait changes in individuals with stroke. Gait Posture. 2007 Feb;25(2):185-90. doi: 10.1016/j.gaitpost.2006.03.007. Epub 2006 May 2.
PubMed 16650766Liu YC, Yang YR, Tsai YA, Wang RY. Cognitive and motor dual task gait training improve dual task gait performance after stroke - A randomized controlled pilot trial. Sci Rep. 2017 Jun 22;7(1):4070. doi: 10.1038/s41598-017-04165-y.
PubMed 28642466Spano B, Lombardi MG, De Tollis M, Szczepanska MA, Ricci C, Manzo A, Giuli S, Polidori L, Griffini IA, Adriano F, Caltagirone C, Annicchiarico R. Effect of Dual-Task Motor-Cognitive Training in Preventing Falls in Vulnerable Elderly Cerebrovascular Patients: A Pilot Study. Brain Sci. 2022 Jan 27;12(2):168. doi: 10.3390/brainsci12020168.
PubMed 35203932Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ. 2016 Oct 24;355:i5239. doi: 10.1136/bmj.i5239.
PubMed 27777223
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Motor-cognitive Training Program in Patients With Traumatic Brain Injury During Acute Hospitalization
- ClinicalTrials.gov ID
- NCT06149975
- Acronym / sponsor ID
- StepIt TBI
- Conditions
- Traumatic Brain Injury
- Keywords
- motor-cognitive training, dual-task, TBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Swiss Federal Institute of TechnologyUniversity, hospital or other
- Collaborators
- Cantonal Hospital of St. Gallen
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 13 Jun 2024 (actual)
- Study completion
- 13 Jun 2024 (actual)
- First posted
- 29 Nov 2023 (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 study is to test feasibility of a motor-cognitive training program in patients after mild to severe traumatic brain injury in an acute hospitalization setting.
The intervention is a step-based dual-task training, i.e. patients are presented with step patterns that they have to memorize and then execute in the tempo given by a metronome.
Researchers will assess the feasibility of the motor-cognitive training regarding acceptance and safety, user evaluation of the training and training performance.
Detailed description
A traumatic brain injury (TBI) refers to a functional disorder of the brain with or without demonstrable injuries to the brain as a result of external force to the skull and/or brain. The most common causes are traffic accidents and falls. After TBI, impairments may occur in motor skills such as gait stability, static and dynamic balance and motor coordination as well as cognitive skills such as memory, dual- and multi-tasking (DT/MT), and psychomotor speed. Therefore, rapid improvement of motor and cognitive functioning and falls prevention are essential.
Dual-task training have been shown to improve gait performance and to reduce the risk of falling in some neurological disorders, such as Parkinson's disease and stroke. Although there are differences in the underlying pathophysiology between these neurological conditions and TBI, research has identified many common fall-risk factors and thus it can be expected that TBI patients would also profit from cognitive-motor dual-task training. However, research on the effects of such training in TBI patients in scarce. To our knowledge, there is only one study that has looked into the effects of dual-task motor-cognitive training in people with neurological conditions, including (but not specifically for) persons with TBI. For this reason, this study aims to assess the feasibility of a concept for stepping training (StepIt) that addresses motor as well as cognitive falls-related aspects in patients with TBI.
This study will be conducted as one-arm, monocentric intervention trial. After admission to the normal ward, patients potentially fulfilling the eligibility criteria will be informed orally and in writing about the study and asked if they wish to participate. All interested participants will then be screened for final inclusion. Baseline data collection will occur prior to the first training session and training evaluation will be conducted after 3 to max. 10 trainings (depending on the length of their hospital stay). During each training session individual training parameters will be documented. In addition to the usual care, the study participants receive the motor-cognitive training "StepIt". The "StepIt" will be conducted as an approximately 15-minute one on one training for at least 3 to max. 10 sessions during the stay at the hospital.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: motor-cognitive trainingIn addition to the usual care, the study participants receive the motor-cognitive training "StepIt". The "StepIt" will be conducted as an approximately 15-minute one on one training for at least 3 to max. 10 sessions during the stay at the hospital. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- People diagnosed with mild (Glasgow Coma Scale 14-15), moderate (Glasgow Coma Scale 9-13) or severe (Glasgow Coma Scale 3-8) TBI
- Age ≥ 18 years
- Planned hospital treatment >24h on regular ward (non-ICU)
- Physically able to stand (using cane if needed)
- Able to give informed consent
Key exclusion criteria (4 listed)
- Limited vision and hearing ability (except facial injuries with monocular swelling)
- Inability or contraindications to undergo the investigated intervention.
- ICU stay only
- Montreal Cognitive Assessment (MoCa) score < 16
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 |
|---|---|---|
| motor-cognitive trainingThe motor-cognitive training in this study will be conducted in form of a step-based dual-task training. A mat (approximately 90 x 90 cm) made from extra non-slip yoga mats is required. The mat is divided into 9 equal squares with a 3 x 3 pattern. Participants will be presented with stepping patterns which they must memorize and then execute on the mat in the pace given by a metronome. All participants will start at the same level. The progression will be adjusted individually according to the fixed criteria of the "StepIt" concept within the sessions. All sessions will be supervised by at least one physical therapist. | Other | Intervention |
Primary outcome
Recruitment rate
Time frame: through study completion, an average of 9 months
Number of patients fitting to the inclusion exclusion (resp. exclusion) criteria as percentages of persons with TBI admitted in the hospital during the study period
Inclusion rate
Time frame: through study completion, an average of 9 months
Number of patients included in the study as percentages of patients fitting to the inclusion (resp. exclusion) criteria
Attrition rate
Time frame: through study completion, an average of 9 months
Number of Drop-outs as percentages of patients included in the study
Adherence rate
Time frame: through study completion, an average of 9 months (over all training sessions)
Number of attended training sessions as percentages of total possible training sessions
Compliance rate
Time frame: through study completion, an average of 9 months (over all training sessions)
Number of attended training minutes as percentages of the total possible training minutes
Security incidents
Time frame: through study completion, an average of 9 months (over all training sessions)
Total number of (Serious) Adverse Events (SAE/AE)
4 secondary outcomes
Physical and cognitive load
Time frame: through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
Patient Satisfaction
Time frame: through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
Improvement
Time frame: through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
Training capacity
Time frame: through study completion, an average of 9 months (after each training session (min. 3 times max. 10 times))
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
- Background: PubMed 21044706Menon DK, Schwab K, Wright DW, Maas AI; Demographics and Clinical Assessment Working Group of the International and Interagency Initiative toward Common Data Elements for Research on Traumatic Brain Injury and Psychological Health. Position statement: definition of traumatic brain injury. Arch Phys Med Rehabil. 2010 Nov;91(11):1637-40. doi: 10.1016/j.apmr.2010.05.017.
- Background: PubMed 26537996Brazinova A, Rehorcikova V, Taylor MS, Buckova V, Majdan M, Psota M, Peeters W, Feigin V, Theadom A, Holkovic L, Synnot A. Epidemiology of Traumatic Brain Injury in Europe: A Living Systematic Review. J Neurotrauma. 2021 May 15;38(10):1411-1440. doi: 10.1089/neu.2015.4126. Epub 2018 Dec 19.
- Background: PubMed 29554850Galea OA, Cottrell MA, Treleaven JM, O'Leary SP. Sensorimotor and Physiological Indicators of Impairment in Mild Traumatic Brain Injury: A Meta-Analysis. Neurorehabil Neural Repair. 2018 Feb;32(2):115-128. doi: 10.1177/1545968318760728.
- Background: PubMed 24529420Rabinowitz AR, Levin HS. Cognitive sequelae of traumatic brain injury. Psychiatr Clin North Am. 2014 Mar;37(1):1-11. doi: 10.1016/j.psc.2013.11.004. Epub 2014 Jan 14.
- Background: PubMed 29154694Berkner J, Meehan WP 3rd, Master CL, Howell DR. Gait and Quiet-Stance Performance Among Adolescents After Concussion-Symptom Resolution. J Athl Train. 2017 Dec;52(12):1089-1095. doi: 10.4085/1062-6050-52.11.23. Epub 2017 Nov 20.
- Background: PubMed 36138943Spano B, De Tollis M, Taglieri S, Manzo A, Ricci C, Lombardi MG, Polidori L, Griffini IA, Aloisi M, Vinicola V, Formisano R, Caltagirone C, Annicchiarico R. The Effect of Dual-Task Motor-Cognitive Training in Adults with Neurological Diseases Who Are at Risk of Falling. Brain Sci. 2022 Sep 7;12(9):1207. doi: 10.3390/brainsci12091207.
- Background: PubMed 31993435Giannouli E, Morat T, Zijlstra W. A Novel Square-Stepping Exercise Program for Older Adults (StepIt): Rationale and Implications for Falls Prevention. Front Med (Lausanne). 2020 Jan 14;6:318. doi: 10.3389/fmed.2019.00318. eCollection 2019.
- Background: PubMed 23364169Fritz NE, Basso DM. Dual-task training for balance and mobility in a person with severe traumatic brain injury: a case study. J Neurol Phys Ther. 2013 Mar;37(1):37-43. doi: 10.1097/NPT.0b013e318282a20d.
- Background: PubMed 34509248Zhou Q, Yang H, Zhou Q, Pan H. Effects of cognitive motor dual-task training on stroke patients: A RCT-based meta-analysis. J Clin Neurosci. 2021 Oct;92:175-182. doi: 10.1016/j.jocn.2021.08.009. Epub 2021 Aug 25.
- Background: PubMed 34391298Silva RDN, Afonso SV, Felipe LR, Oliveira RA, Patrizzi Martins LJ, Pascucci Sande de Souza LA. Dual-task intervention based on trail making test: Effects on Parkinson's disease. J Bodyw Mov Ther. 2021 Jul;27:628-633. doi: 10.1016/j.jbmt.2021.04.013. Epub 2021 May 4.
- Background: PubMed 16650766Yang YR, Chen YC, Lee CS, Cheng SJ, Wang RY. Dual-task-related gait changes in individuals with stroke. Gait Posture. 2007 Feb;25(2):185-90. doi: 10.1016/j.gaitpost.2006.03.007. Epub 2006 May 2.
- Background: PubMed 28642466Liu YC, Yang YR, Tsai YA, Wang RY. Cognitive and motor dual task gait training improve dual task gait performance after stroke - A randomized controlled pilot trial. Sci Rep. 2017 Jun 22;7(1):4070. doi: 10.1038/s41598-017-04165-y.
Related trials for Traumatic Brain Injury
Active, not recruiting
TMS-fNIRS Personalized Dosing
Post Traumatic Stress Disorder, Traumatic Brain Injury
Recruiting
Middle Meningeal Artery Embolisation in Chronic Subdural Hematoma
Chronic Subdural Hematoma
Recruiting
Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Traumatic Brain Injury
Not yet recruitingPhase 2/3
Valproic AcId for Traumatic BRAin INjury Trial
Moderate Traumatic Brain Injury (TBI), Severe Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
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.
Anne-Katrin Hickmann, PD Dr. study director
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing motor-cognitive training in people with Traumatic Brain Injury, run by Swiss Federal Institute of Technology at 1 site in Switzerland.
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 5 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: finished, as of the sponsor's last update on 3 Jul 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 Switzerland. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: through study completion, an average of 9 months). The study lists 6 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 NCT06149975, which also lists 14 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 3 Jul 2024.