Clinical trial NCT03666039: Reversing Maladaptive Reorganization in Frail Brains
Official title: Reversing Maladaptive Reorganization in Frail Brains: Sensorimotor Training, Brain Plasticity and the Role of Brain-derived Neurotrophic Factor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neuroplasticity
Sensorimotor
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
First posted: 2018-09-11
Enrollment: 66
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: Inclusion Criteria:

* Frail individuals (Fried criteria)

Exclusion Criteria:

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

Primary outcomes:
measure: Neuroplasticity measures of brain Imaging I: brain responses at rest and task-based (sensorimotor)
timeFrame: 2 months
measure: Body parameter: weight and height
timeFrame: 2 months
measure: Body parameter: muscles
timeFrame: 2 months
measure: Neuroplasticity measures of brain Imaging: brain size
timeFrame: 2 months
measure: Neuroplasticity measures of brain Imaging: brain diffusion
timeFrame: 2 months
Secondary outcomes:
measure: Well-being
timeFrame: 2-3 months
measure: Cognitive health
timeFrame: 2-3 months
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: CIMH - Department of Cognitive and Clinical Neuroscience
Study officials:
References:
citation: Beier 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.
citation: Beier 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.