Traumatic Brain InjuryPhase 1NCT03407924
Exercise and Rehabilitation After Traumatic Brain Injury
A Phase 1 study testing Aerobic Exercise (AER) and Rehabilitation in people with Traumatic Brain Injury, run by Centre for Neuro Skills at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of exercise on recovery after traumatic brain injury. Investigators will determine if exercise enhances rehabilitation by increasing substances (proteins) that can facilitate recovery. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- Aerobic Exercise (AER) and Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to Mar 2022
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Clinical diagnosis of TBI (for R+AER and R groups).
- Fluency in English or Spanish.
- Able to walk with or without a device.
Who cannot join
- Orthopedic or cardiac conditions that prevent from exercising.
- Current diagnosis of neurological and/or psychiatric diseases.
- Unable to be in the Los Angeles CA metropolitan area for the duration of the study
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Centre for Neuro Skills
Encino, California, 91436
Grace Griesbach, PhD, 818-783-3800, researchcentre@neuroskills.com
Charan Singh, MS, (661)872-3408, csingh@neuroskills.com
About this study
Official title: Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury
The purpose of this study is to examine the effects of exercise on recovery after traumatic brain injury. Investigators will determine if exercise enhances rehabilitation by increasing substances (proteins) that can facilitate recovery.
Read the detailed description
Exercise-based therapies can promote recovery of function and are easily implemented in the clinical rehabilitation setting. This study will determine if exercise facilitates recovery by improving markers of neuroplasticity and decreasing neuroinflammatory responses. The investigators will also determine if variations in genes involved in neuroplasticity, memory and inflammation influence the responsiveness to exercise and rehabilitation. Particular genetic polymorphisms involved in neuroplasticity and inflammatory responses will be evaluated. Recovery will be determined by assessing cognitive function, life quality and balance.
- Conditions
- Traumatic Brain Injury
- Being tested
- Aerobic Exercise (AER), Rehabilitation
- 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.
Aerobic Exercise (AER)Other
Aerobic exercise will be performed with a treadmill or stationary tandem bike 3 times per week. Each exercise session will take about 30 minutes plus 5 to 10 min of warm-up and cool-down. Participants will wear a safety harness.
RehabilitationOther
Rehabilitative program is focused on completion of activities of daily living, initiation, appropriate behavior and community integration for five days per week at the Centre for Neuro Skills.
| Study group | Role | What they receive |
|---|---|---|
| Intervention aerobic exercise (AER) | Experimental | Participants with traumatic brain injury (TBI) that are enrolled in a comprehensive rehabilitation program (R) will be engaged in an aerobic exercise program (AER). These participants will also receive standard rehabilitation which includes exercise within the physical therapy session. Given that the duration of the rehabilitative program is variable the period of AER training will be no less than 4 weeks and will not exceed 30 weeks. Activity levels will be monitored. Receives: Other: Aerobic Exercise (AER); Other: Rehabilitation |
| rehabilitation (R) | Active comparator | Participants with traumatic brain injury that are enrolled in a comprehensive rehabilitation program. These participants will receive standard rehabilitation. Given that the duration of the rehabilitative program is variable the duration of participation will be no less than 4 weeks and will not exceed 30 weeks. Activity levels will be monitored. Receives: Other: Rehabilitation |
| control (C) | No intervention | Healthy volunteers' responsiveness to exercise and activity levels will be determined to detect TBI effects. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Exercise Induced Changes in Inflammatory responses to exercise
Selected analytes will be evaluated from serum.
Measured: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Aerobic Exercise Induced Changes in Cognitive Function
Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs. All scores are aggregated to one reported value (Neurocognitive Index). Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.
Measured: 5 years
Aerobic Exercise Induced Changes in Cardio Pulmonary Fitness
Ventilatory Threshold (aerobic capacity)
Measured: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise
Selected analytes will be evaluated from serum.
Measured: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Secondary outcomes (2)
Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.
Genetic material will be obtained.
Measured: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Aerobic Exercise Induced Changes in Depression Symptoms
Beck Depression Inventory
Measured: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study startJun 2016
- Primary completionMar 2020 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Intervention will consist of aerobic exercise sessions at predetermined heart rate range.
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre for Neuro Skills
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Grace S. Griesbach, Centre for Neuro Skills
- Investigators
- Grace S Griesbach, PhD, Principal investigator, Centre for Neuro Skills
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03407924
- Sponsor's protocol ID
- AER-TBI1
- Status last verified
- Jan 2018
- First submitted
- 9 Jul 2015
- Last updated
- 30 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Griesbach GS, Hovda DA, Molteni R, Wu A, Gomez-Pinilla F. Voluntary exercise following traumatic brain injury: brain-derived neurotrophic factor upregulation and recovery of function. Neuroscience. 2004;125(1):129-39. doi: 10.1016/j.neuroscience.2004.01.030.
PubMed 15051152Hellawell DJ, Taylor RT, Pentland B. Cognitive and psychosocial outcome following moderate or severe traumatic brain injury. Brain Inj. 1999 Jul;13(7):489-504. doi: 10.1080/026990599121403.
PubMed 10462147Ashman TA, Gordon WA, Cantor JB, Hibbard MR. Neurobehavioral consequences of traumatic brain injury. Mt Sinai J Med. 2006 Nov;73(7):999-1005.
PubMed 17195886Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93. doi: 10.1097/NPT.0b013e3181dde568.
PubMed 20588094Chamelian L, Feinstein A. Outcome after mild to moderate traumatic brain injury: the role of dizziness. Arch Phys Med Rehabil. 2004 Oct;85(10):1662-6. doi: 10.1016/j.apmr.2004.02.012.
PubMed 15468028Agrawal M, Joshi M. Impact of rehabilitation on functional outcome during the first year of moderate and severe traumatic brain injury. Brain Inj. 2014;28(3):292-7. doi: 10.3109/02699052.2013.865266. Epub 2013 Dec 30.
PubMed 24378157Griesbach GS, Kreber LA, Harrington D, Ashley MJ. Post-acute traumatic brain injury rehabilitation: effects on outcome measures and life care costs. J Neurotrauma. 2015 May 15;32(10):704-11. doi: 10.1089/neu.2014.3754. Epub 2015 Feb 11.
PubMed 25496475Chandrasekhar SS. The assessment of balance and dizziness in the TBI patient. NeuroRehabilitation. 2013;32(3):445-54. doi: 10.3233/NRE-130867.
PubMed 23648599Ridgel AL, Vitek JL, Alberts JL. Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):600-8. doi: 10.1177/1545968308328726. Epub 2009 Jan 8.
PubMed 19131578
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03407924
- Acronym / sponsor ID
- AER-TBI1
- Conditions
- Traumatic Brain Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Centre for Neuro SkillsIndustry (pharma, biotech, devices)
- Study start
- Jun 2016
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 23 Jan 2018 (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 purpose of this study is to examine the effects of exercise on recovery after traumatic brain injury. Investigators will determine if exercise enhances rehabilitation by increasing substances (proteins) that can facilitate recovery.
Detailed description
Exercise-based therapies can promote recovery of function and are easily implemented in the clinical rehabilitation setting. This study will determine if exercise facilitates recovery by improving markers of neuroplasticity and decreasing neuroinflammatory responses. The investigators will also determine if variations in genes involved in neuroplasticity, memory and inflammation influence the responsiveness to exercise and rehabilitation. Particular genetic polymorphisms involved in neuroplasticity and inflammatory responses will be evaluated. Recovery will be determined by assessing cognitive function, life quality and balance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Intervention will consist of aerobic exercise sessions at predetermined heart rate range.
| Arm | Type | Receives |
|---|---|---|
| Intervention aerobic exercise (AER) | Experimental | Other: Aerobic Exercise (AER), Other: RehabilitationParticipants with traumatic brain injury (TBI) that are enrolled in a comprehensive rehabilitation program (R) will be engaged in an aerobic exercise program (AER). These participants will also receive standard rehabilitation which includes exercise within the physical therapy session. Given that the duration of the rehabilitative program is variable the period of AER training will be no less than 4 weeks and will not exceed 30 weeks. Activity levels will be monitored. |
| rehabilitation (R) | Active comparator | Other: RehabilitationParticipants with traumatic brain injury that are enrolled in a comprehensive rehabilitation program. These participants will receive standard rehabilitation. Given that the duration of the rehabilitative program is variable the duration of participation will be no less than 4 weeks and will not exceed 30 weeks. Activity levels will be monitored. |
| control (C) | No intervention | –Healthy volunteers' responsiveness to exercise and activity levels will be determined to detect TBI effects. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of TBI (for R+AER and R groups).
- Fluency in English or Spanish.
- Able to walk with or without a device.
Key exclusion criteria (3 listed)
- Orthopedic or cardiac conditions that prevent from exercising.
- Current diagnosis of neurological and/or psychiatric diseases.
- Unable to be in the Los Angeles CA metropolitan area for the duration of the study
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 |
|---|---|---|
| Aerobic Exercise (AER)Aerobic exercise will be performed with a treadmill or stationary tandem bike 3 times per week. Each exercise session will take about 30 minutes plus 5 to 10 min of warm-up and cool-down. Participants will wear a safety harness. | Other | Intervention aerobic exercise (AER) |
| RehabilitationRehabilitative program is focused on completion of activities of daily living, initiation, appropriate behavior and community integration for five days per week at the Centre for Neuro Skills. | Other | Intervention aerobic exercise (AER), rehabilitation (R) |
Primary outcome
Aerobic Exercise Induced Changes in Inflammatory responses to exercise
Time frame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Selected analytes will be evaluated from serum.
Aerobic Exercise Induced Changes in Cognitive Function
Time frame: 5 years
Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs. All scores are aggregated to one reported value (Neurocognitive Index). Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.
Aerobic Exercise Induced Changes in Cardio Pulmonary Fitness
Time frame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Ventilatory Threshold (aerobic capacity)
Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise
Time frame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Selected analytes will be evaluated from serum.
2 secondary outcomes
Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.
Time frame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Aerobic Exercise Induced Changes in Depression Symptoms
Time frame: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2018.
- Background: PubMed 15051152Griesbach GS, Hovda DA, Molteni R, Wu A, Gomez-Pinilla F. Voluntary exercise following traumatic brain injury: brain-derived neurotrophic factor upregulation and recovery of function. Neuroscience. 2004;125(1):129-39. doi: 10.1016/j.neuroscience.2004.01.030.
- Background: PubMed 10462147Hellawell DJ, Taylor RT, Pentland B. Cognitive and psychosocial outcome following moderate or severe traumatic brain injury. Brain Inj. 1999 Jul;13(7):489-504. doi: 10.1080/026990599121403.
- Background: PubMed 17195886Ashman TA, Gordon WA, Cantor JB, Hibbard MR. Neurobehavioral consequences of traumatic brain injury. Mt Sinai J Med. 2006 Nov;73(7):999-1005.
- Background: PubMed 20588094Alsalaheen BA, Mucha A, Morris LO, Whitney SL, Furman JM, Camiolo-Reddy CE, Collins MW, Lovell MR, Sparto PJ. Vestibular rehabilitation for dizziness and balance disorders after concussion. J Neurol Phys Ther. 2010 Jun;34(2):87-93. doi: 10.1097/NPT.0b013e3181dde568.
- Background: PubMed 15468028Chamelian L, Feinstein A. Outcome after mild to moderate traumatic brain injury: the role of dizziness. Arch Phys Med Rehabil. 2004 Oct;85(10):1662-6. doi: 10.1016/j.apmr.2004.02.012.
- Background: PubMed 24378157Agrawal M, Joshi M. Impact of rehabilitation on functional outcome during the first year of moderate and severe traumatic brain injury. Brain Inj. 2014;28(3):292-7. doi: 10.3109/02699052.2013.865266. Epub 2013 Dec 30.
- Background: PubMed 25496475Griesbach GS, Kreber LA, Harrington D, Ashley MJ. Post-acute traumatic brain injury rehabilitation: effects on outcome measures and life care costs. J Neurotrauma. 2015 May 15;32(10):704-11. doi: 10.1089/neu.2014.3754. Epub 2015 Feb 11.
- Background: PubMed 23648599Chandrasekhar SS. The assessment of balance and dizziness in the TBI patient. NeuroRehabilitation. 2013;32(3):445-54. doi: 10.3233/NRE-130867.
- Background: PubMed 19131578Ridgel AL, Vitek JL, Alberts JL. Forced, not voluntary, exercise improves motor function in Parkinson's disease patients. Neurorehabil Neural Repair. 2009 Jul-Aug;23(6):600-8. doi: 10.1177/1545968308328726. Epub 2009 Jan 8.
- Individual participant dataSharing planned: Undecided
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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.
Grace S Griesbach, PhD principal investigator
Centre for Neuro Skills
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Aerobic Exercise (AER) and Rehabilitation in people with Traumatic Brain Injury, run by Centre for Neuro Skills at 1 site in United States.
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 3 inclusion and 3 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 30 Jan 2018. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Grace S Griesbach, PhD ((818)783-3800, researchcentre@neuroskills.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Exercise Induced Changes in Inflammatory responses to exercise (time frame: 4 to 30 weeks depending on the duration of rehabilitation coverage.). The study lists 4 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 NCT03407924, which also lists 9 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 30 Jan 2018.