NCT03666039: FRAILBRAIN

Reversing Maladaptive Reorganization in Frail Brains

Completed NA Last updated 19 July 2022

What this trial tests

NA trial testing Trainings app in Neuroplasticity in 66 participants. Completed in 31 December 2021.

Timeline

1 October 2017

Primary endpoint
1 September 2021

31 December 2021

Quick facts

Lead sponsor	Central Institute of Mental Health, Mannheim
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	basic science
Enrollment	66
Start date	1 October 2017
Primary completion	1 September 2021
Estimated completion	31 December 2021
Sites	1 location across Germany

Drugs / interventions tested

• Trainings app

Conditions studied

• Neuroplasticity — all drugs for Neuroplasticity →
• Sensorimotor — all drugs for Sensorimotor →

Sponsor

Central Institute of Mental Health, Mannheim

Who can join

65 and older, any sex, with Neuroplasticity or Sensorimotor. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Sensory and motor correlates of frailty: dissociation between frailty phenotype and frailty index.
   Beier F, Löffler M, Nees F, Hausner L, et al · · 2022 · cited 8× · PMID 36109693 · DOI 10.1186/s12877-022-03416-6
2. Effects of an app-based sensorimotor training in promoting neuroplasticity and neuropsychological functioning in frailty: A randomized controlled trial.
   Beier F, Löffler M, Nees F, Bekrater-Bodmann R, et al · · 2023 · cited 3× · PMID 37776754 · DOI 10.1016/j.archger.2023.105202
3. Promoting neuroplasticity and neuropsychological functioning in frailty through an app-based sensorimotor training: study protocol for a randomized trial.
   Beier F, Löffler M, Nees F, Hausner L, et al · · 2021 · cited 3× · PMID 34082710 · DOI 10.1186/s12877-021-02293-9