NeuroplasticityFRAILBRAINNCT03666039
Reversing Maladaptive Reorganization in Frail Brains
A study testing Trainings app in people with Neuroplasticity and Sensorimotor, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
Neuroscientific models of maladaptive aging emphasize the loss of sensorimotor stimulation and reduced modulatory capacities as core processes in the development of maladaptive plastic changes of the brain and subsequent cognitive and bodily decline as determinants of frailty and multimorbidity in old age. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Neuroplasticity, Sensorimotor
- What is being tested?
- Trainings app
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteGermany
- Study dates
- 1 Oct 2017to 31 Dec 2021
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Frail individuals (Fried criteria)
Who cannot join
- Alzheimer or strong cognitive/dementia impairments, strong neurological impairments, age below 65
Trial locations and contacts
1 site in 1 country.
Germany1 site
CIMH - Department of Cognitive and Clinical Neuroscience
Mannheim, 68159
About this study
Official title: Reversing Maladaptive Reorganization in Frail Brains: Sensorimotor Training, Brain Plasticity and the Role of Brain-derived Neurotrophic Factor
Neuroscientific models of maladaptive aging emphasize the loss of sensorimotor stimulation and reduced modulatory capacities as core processes in the development of maladaptive plastic changes of the brain and subsequent cognitive and bodily decline as determinants of frailty and multimorbidity in old age. The investigators plan to analyze anatomical, neurophysiological, and neuropsychological correlates of maladaptive plasticity in frail persons and plan to test how innovative interventions that target maladaptive plasticity alter brain function and neurocognitive skills. There are novel interventions that have been shown to target the neurocognitive deficits and enhance plasticity in brain areas that are affected first in the progress of aging. Specifically, sensory training has been employed to enhance relevant input to the brain and to improve neuromodulatory function and has yielded high effect sizes. The investigators will perform proof of concept studies to examine the utility of sensorimotor training and examine the role of brain-derived neurotrophic growth factor to enhance brain plasticity and memory functions, as well as their transfer to other cognitive domains. The investigators will implement motivational enhancement strategies using virtual reality in these treatments that can further boost training effects and plasticity, but have not been employed in these treatments so far. Biomarkers for the remediation of maladaptive changes will involve neuropsychological assessments, brain imaging, brain-derived neurotrophic factor (BDNF) levels, and BDNF genotype. Thus, the investigators will be able to comprehensively characterize dysfunctional plasticity and the specific mechanisms of the interventions that are employed and investigate innovative clinical trials.
- Conditions
- Neuroplasticity, Sensorimotor
- Being tested
- Trainings app
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trainings appBehavioural
Sensorimotor trainings app for at home Training (tablet-based)
| Study group | Role | What they receive |
|---|---|---|
| Sensorimotor training | Experimental | The participants will receive a tablet-based app for at home training that contains sensorimotor components. Receives: Behavioral: Trainings app |
| Control training | Active comparator | The participants will receive a tablet-based app for at home training that contains relaxing components. Receives: Behavioral: Trainings app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuroplasticity measures of brain Imaging I: brain responses at rest and task-based (sensorimotor)
Blood oxygenation level dependent (BOLD) signal changes
Measured: 2 months
Body parameter: weight and height
Information on weight and height will be combined to report BMI in kg/m^2
Measured: 2 months
Body parameter: muscles
Muscle strength in electromyogram amplitudes
Measured: 2 months
Neuroplasticity measures of brain Imaging: brain size
Volume of different brain regions
Measured: 2 months
Neuroplasticity measures of brain Imaging: brain diffusion
Brain diffusion in fractional anisotropy values
Measured: 2 months
Secondary outcomes (2)
Well-being
Questionnaire data on mood and mental health will be standardized and integrated into one mean score of well-being (computation of a mean values across the questionnaire scores)
Measured: 2-3 months
Cognitive health
Behavioral performance data during cognitive testing will be standardized integrated into one mean score of cognitive functioning (computation of a mean value across response times in the cogniitve tests)
Measured: 2-3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start1 Oct 2017
- Primary completion1 Sep 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for NeuroplasticityStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Herta Flor, Central Institute of Mental Health, Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03666039
- Sponsor's protocol ID
- FRAILBRAIN
- Acronym
- FRAILBRAIN
- Status last verified
- Jul 2022
- First submitted
- 4 Sep 2018
- Last updated
- 19 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Beier F, Loffler M, Nees F, Bekrater-Bodmann R, Silvoni S, Desch S, Loffler A, Hausner L, Frolich L, Flor H. Effects of an app-based sensorimotor training in promoting neuroplasticity and neuropsychological functioning in frailty: A randomized controlled trial. Arch Gerontol Geriatr. 2023 Dec;115:105202. doi: 10.1016/j.archger.2023.105202. Epub 2023 Sep 17.
PubMed 37776754Beier F, Loffler M, Nees F, Hausner L, Frolich L, Flor H. Sensory and motor correlates of frailty: dissociation between frailty phenotype and frailty index. BMC Geriatr. 2022 Sep 15;22(1):755. doi: 10.1186/s12877-022-03416-6.
PubMed 36109693Beier F, Loffler M, Nees F, Hausner L, Frolich L, Flor H. Promoting neuroplasticity and neuropsychological functioning in frailty through an app-based sensorimotor training: study protocol for a randomized trial. BMC Geriatr. 2021 Jun 3;21(1):343. doi: 10.1186/s12877-021-02293-9.
PubMed 34082710
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reversing Maladaptive Reorganization in Frail Brains: Sensorimotor Training, Brain Plasticity and the Role of Brain-derived Neurotrophic Factor
- ClinicalTrials.gov ID
- NCT03666039
- Acronym / sponsor ID
- FRAILBRAIN / FRAILBRAIN
- Conditions
- Neuroplasticity, Sensorimotor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Study start
- 1 Oct 2017 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 11 Sep 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.
Neuroscientific models of maladaptive aging emphasize the loss of sensorimotor stimulation and reduced modulatory capacities as core processes in the development of maladaptive plastic changes of the brain and subsequent cognitive and bodily decline as determinants of frailty and multimorbidity in old age. The investigators plan to analyze anatomical, neurophysiological, and neuropsychological correlates of maladaptive plasticity in frail persons and plan to test how innovative interventions that target maladaptive plasticity alter brain function and neurocognitive skills. There are novel interventions that have been shown to target the neurocognitive deficits and enhance plasticity in brain areas that are affected first in the progress of aging. Specifically, sensory training has been employed to enhance relevant input to the brain and to improve neuromodulatory function and has yielded high effect sizes. The investigators will perform proof of concept studies to examine the utility of sensorimotor training and examine the role of brain-derived neurotrophic growth factor to enhance brain plasticity and memory functions, as well as their transfer to other cognitive domains. The investigators will implement motivational enhancement strategies using virtual reality in these treatments that can further boost training effects and plasticity, but have not been employed in these treatments so far. Biomarkers for the remediation of maladaptive changes will involve neuropsychological assessments, brain imaging, brain-derived neurotrophic factor (BDNF) levels, and BDNF genotype. Thus, the investigators will be able to comprehensively characterize dysfunctional plasticity and the specific mechanisms of the interventions that are employed and investigate innovative clinical trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sensorimotor training | Experimental | Behavioral: Trainings appThe participants will receive a tablet-based app for at home training that contains sensorimotor components. |
| Control training | Active comparator | Behavioral: Trainings appThe participants will receive a tablet-based app for at home training that contains relaxing components. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Frail individuals (Fried criteria)
Key exclusion criteria (1 listed)
- Alzheimer or strong cognitive/dementia impairments, strong neurological impairments, age below 65
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 |
|---|---|---|
| Trainings appSensorimotor trainings app for at home Training (tablet-based) | Behavioural | Control training, Sensorimotor training |
Primary outcome
Neuroplasticity measures of brain Imaging I: brain responses at rest and task-based (sensorimotor)
Time frame: 2 months
Blood oxygenation level dependent (BOLD) signal changes
Body parameter: weight and height
Time frame: 2 months
Information on weight and height will be combined to report BMI in kg/m^2
Body parameter: muscles
Time frame: 2 months
Muscle strength in electromyogram amplitudes
Neuroplasticity measures of brain Imaging: brain size
Time frame: 2 months
Volume of different brain regions
Neuroplasticity measures of brain Imaging: brain diffusion
Time frame: 2 months
Brain diffusion in fractional anisotropy values
2 secondary outcomes
Well-being
Time frame: 2-3 months
Cognitive health
Time frame: 2-3 months
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 19 Jul 2022.
- Derived from this study: PubMed 37776754Beier F, Loffler M, Nees F, Bekrater-Bodmann R, Silvoni S, Desch S, Loffler A, Hausner L, Frolich L, Flor H. Effects of an app-based sensorimotor training in promoting neuroplasticity and neuropsychological functioning in frailty: A randomized controlled trial. Arch Gerontol Geriatr. 2023 Dec;115:105202. doi: 10.1016/j.archger.2023.105202. Epub 2023 Sep 17.
- Derived from this study: PubMed 36109693Beier F, Loffler M, Nees F, Hausner L, Frolich L, Flor H. Sensory and motor correlates of frailty: dissociation between frailty phenotype and frailty index. BMC Geriatr. 2022 Sep 15;22(1):755. doi: 10.1186/s12877-022-03416-6.
- Derived from this study: PubMed 34082710Beier F, Loffler M, Nees F, Hausner L, Frolich L, Flor H. Promoting neuroplasticity and neuropsychological functioning in frailty through an app-based sensorimotor training: study protocol for a randomized trial. BMC Geriatr. 2021 Jun 3;21(1):343. doi: 10.1186/s12877-021-02293-9.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trainings app in people with Neuroplasticity and Sensorimotor, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
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 1 inclusion and 1 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 19 Jul 2022. 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 Germany. 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?
Neuroplasticity measures of brain Imaging I: brain responses at rest and task-based (sensorimotor) (time frame: 2 months). The study lists 5 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 NCT03666039, which also lists 3 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 19 Jul 2022.