Reversing Maladaptive Reorganization in Frail Brains

NCT ID: NCT03666039

Last Updated: 2022-07-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-01
• Study Completion Date: 2021-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Sensorimotor training

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

Group Type: EXPERIMENTAL

Trainings app

Intervention Type: BEHAVIORAL

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

Control training

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

Group Type: ACTIVE_COMPARATOR

Trainings app

Intervention Type: BEHAVIORAL

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

Interventions

Trainings app

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Frail individuals (Fried criteria)

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role: lead

Responsible Party

Prof Herta Flor

Scientific Director, Prof. Dr. Dr. h.c.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

CIMH - Department of Cognitive and Clinical Neuroscience

Mannheim, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 37776754 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36109693 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34082710 (View on PubMed)

Other Identifiers

FRAILBRAIN

Identifier Type: -

Identifier Source: org_study_id