Reversing Maladaptive Reorganization in Frail Brains

Neuroplasticity Clinical Trial

— FRAILBRAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666039
• Other study ID #: FRAILBRAIN
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: July 2022
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 31, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Frail individuals (Fried criteria)

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Neuroplasticity
• Sensorimotor

Intervention

Behavioral:
• Trainings app
Sensorimotor trainings app for at home Training (tablet-based)

Locations

Country	Name	City	State
Germany	CIMH - Department of Cognitive and Clinical Neuroscience	Mannheim

Sponsors (1)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neuroplasticity measures of brain Imaging I: brain responses at rest and task-based (sensorimotor)	Blood oxygenation level dependent (BOLD) signal changes	2 months
Primary	Body parameter: weight and height	Information on weight and height will be combined to report BMI in kg/m^2	2 months
Primary	Body parameter: muscles	Muscle strength in electromyogram amplitudes	2 months
Primary	Neuroplasticity measures of brain Imaging: brain size	Volume of different brain regions	2 months
Primary	Neuroplasticity measures of brain Imaging: brain diffusion	Brain diffusion in fractional anisotropy values	2 months
Secondary	Well-being	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)	2-3 months
Secondary	Cognitive health	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)	2-3 months