FRAILBRAIN: Reversing Maladaptive Reorganization in Frail Brains

Sponsor

Central Institute of Mental Health, Mannheim (Other)

Overall Status

Completed

CT.gov ID

NCT03666039

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuroplasticity Sensorimotor	Behavioral: Trainings app	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

Reversing Maladaptive Reorganization in Frail Brains: Sensorimotor Training, Brain Plasticity and the Role of Brain-derived Neurotrophic Factor

Actual Study Start Date :

Oct 1, 2017

Actual Primary Completion Date :

Sep 1, 2021

Actual Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sensorimotor training The participants will receive a tablet-based app for at home training that contains sensorimotor components.	Behavioral: Trainings app Sensorimotor trainings app for at home Training (tablet-based)
Active Comparator: Control training The participants will receive a tablet-based app for at home training that contains relaxing components.	Behavioral: Trainings app Sensorimotor trainings app for at home Training (tablet-based)

Arm

Intervention/Treatment

Experimental: Sensorimotor training

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

Behavioral: Trainings app

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

Active Comparator: Control training

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

Behavioral: Trainings app

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

Outcome Measures

Primary Outcome Measures

Neuroplasticity measures of brain Imaging I: brain responses at rest and task-based (sensorimotor) [2 months]
Blood oxygenation level dependent (BOLD) signal changes
Body parameter: weight and height [2 months]
Information on weight and height will be combined to report BMI in kg/m^2
Body parameter: muscles [2 months]
Muscle strength in electromyogram amplitudes
Neuroplasticity measures of brain Imaging: brain size [2 months]
Volume of different brain regions
Neuroplasticity measures of brain Imaging: brain diffusion [2 months]
Brain diffusion in fractional anisotropy values

Secondary Outcome Measures

Well-being [2-3 months]
Questionnaire data on mood and mental health will be standardized and integrated into one mean score of well-being (computation of a mean values across the questionnaire scores)
Cognitive health [2-3 months]
Behavioral performance data during cognitive testing will be standardized integrated into one mean score of cognitive functioning (computation of a mean value across response times in the cogniitve tests)

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Frail individuals (Fried criteria)

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CIMH - Department of Cognitive and Clinical Neuroscience	Mannheim		Germany	68159

Sponsors and Collaborators

Central Institute of Mental Health, Mannheim

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Prof Herta Flor, Scientific Director, Prof. Dr. Dr. h.c., Central Institute of Mental Health, Mannheim

ClinicalTrials.gov Identifier:

NCT03666039

Other Study ID Numbers:

FRAILBRAIN

First Posted:

Sep 11, 2018

Last Update Posted:

Jul 19, 2022

Last Verified:

Jul 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 19, 2022