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Reversing Maladaptive Reorganization in Frail Brains (FRAILBRAIN)

C

Central Institute of Mental Health, Mannheim

Status

Completed

Conditions

Neuroplasticity
Sensorimotor

Treatments

Behavioral: Trainings app

Study type

Interventional

Funder types

Other

Identifiers

NCT03666039
FRAILBRAIN

Details and patient eligibility

About

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.

Enrollment

66 patients

Sex

All

Ages

65+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Frail individuals (Fried criteria)

Exclusion criteria

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

66 participants in 2 patient groups

Sensorimotor training
Experimental group
Description:
The participants will receive a tablet-based app for at home training that contains sensorimotor components.
Treatment:
Behavioral: Trainings app
Control training
Active Comparator group
Description:
The participants will receive a tablet-based app for at home training that contains relaxing components.
Treatment:
Behavioral: Trainings app

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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