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Reversing Maladaptive Reorganization in Frail Brains

Reversing Maladaptive Reorganization in Frail Brains: Sensorimotor Training, Brain Plasticity and the Role of Brain-derived Neurotrophic Factor

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03666039
Acronym
FRAILBRAIN
Enrollment
66
Registered
2018-09-11
Start date
2017-10-01
Completion date
2021-12-31
Last updated
2022-07-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuroplasticity, Sensorimotor

Brief 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. 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.

Interventions

BEHAVIORALTrainings app

Sensorimotor trainings app for at home Training (tablet-based)

Sponsors

Central Institute of Mental Health, Mannheim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Frail individuals (Fried criteria)

Exclusion criteria

* Alzheimer or strong cognitive/dementia impairments, strong neurological impairments, age below 65

Design outcomes

Primary

MeasureTime frameDescription
Body parameter: weight and height2 monthsInformation on weight and height will be combined to report BMI in kg/m\^2
Neuroplasticity measures of brain Imaging: brain size2 monthsVolume of different brain regions
Neuroplasticity measures of brain Imaging: brain diffusion2 monthsBrain diffusion in fractional anisotropy values
Neuroplasticity measures of brain Imaging I: brain responses at rest and task-based (sensorimotor)2 monthsBlood oxygenation level dependent (BOLD) signal changes
Body parameter: muscles2 monthsMuscle strength in electromyogram amplitudes

Secondary

MeasureTime frameDescription
Cognitive health2-3 monthsBehavioral 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)
Well-being2-3 monthsQuestionnaire 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)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026