Reversing Maladaptive Reorganization in Frail Brains

NCT03666039 | Completed

• 1 other identifier: FRAILBRAIN
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Neuroplasticity; Sensorimotor

Outcome Measures

Primary Outcomes (5)

• Neuroplasticity measures of brain Imaging I: brain responses at rest and task-based (sensorimotor)

  Blood oxygenation level dependent (BOLD) signal changes

  2 months

• Body parameter: weight and height

  Information on weight and height will be combined to report BMI in kg/m\^2

  2 months

• Body parameter: muscles

  Muscle strength in electromyogram amplitudes

  2 months

• Neuroplasticity measures of brain Imaging: brain size

  Volume of different brain regions

  2 months

• Neuroplasticity measures of brain Imaging: brain diffusion

  Brain diffusion in fractional anisotropy values

  2 months

Secondary Outcomes (2)

• Well-being

  2-3 months

• Cognitive health

  2-3 months

Study Arms (2)

Sensorimotor training

EXPERIMENTAL

The participants will receive a tablet-based app for at home training that contains sensorimotor components.

Behavioral: Trainings app

Control training

ACTIVE COMPARATOR

The participants will receive a tablet-based app for at home training that contains relaxing components.

Behavioral: Trainings app

Interventions

Trainings app BEHAVIORAL

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

Control training; Sensorimotor training

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Frail individuals (Fried criteria)

You may not qualify if:

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

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead

Study Sites (1)

CIMH - Department of Cognitive and Clinical Neuroscience

Mannheim, 68159, Germany

Location

Related Publications (3)

• 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.

  PMID: 37776754 DERIVED

• 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.

  PMID: 36109693 DERIVED

• 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.

  PMID: 34082710 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Director, Prof. Dr. Dr. h.c.

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 11, 2018
• Study Start: October 1, 2017
• Primary Completion: September 1, 2021
• Study Completion: December 31, 2021
• Last Updated: July 19, 2022

Record last verified: 2022-07

Locations

DE (1)