Association Between Balance and the Integrity of Cerebellar White Matter Tracts in a Healthy Population

• Sponsor: The Catholic University of Korea (Other)
• Overall Status: Completed
• CT.gov ID: NCT04934319
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.3
• Patients Per Site Per Month: 3

Study Details

Study Description

Brief Summary

The cerebellum is involved in regulating balance and walking and plays a crucial role in the locomotor adaptation and learning processes. This study aims to investigate the association between balance and the integrity of the cerebellar white matter tracts in a healthy population. Healthy participants will undergo four weeks of balance training. The investigators will analyze changes in the microstructural integrity of the cerebellar white matter tract before and after four weeks of balance training.

Condition or Disease	Intervention/Treatment	Phase
Balance; Cerebellum	Behavioral: Balance and Proprioceptive Training	N/A

Detailed Description

The cerebellum is involved in regulating balance and walking and plays a crucial role in the locomotor adaptation and learning processes. The cerebellum's intermediate zone, which receives afferent stimuli from the sensorimotor cortex (via the cortico-ponto-cerebellar tract) and peripheral muscles (via the dorsal spinocerebellar tract), contributes to maintaining body posture and regulating walking. Proprioceptive information from the peripheral muscles passes through the dorsal spinocerebellar tract, enters the ipsilateral cerebellar hemisphere via the inferior cerebellar peduncle, and finally projects to the contralateral motor cortex through the cerebello-thalamo-cortical pathways.

Diffusion tensor imaging (DTI) enables microstructural evaluation of the white matter tracts. Both diffusion tensor tractography, to determine the structural connectivity of the whole tract, and DTI-derived parameters, to determine the microstructural organization, can represent the integrity of the cerebellar white matter tracts.

The investigators will evaluate the motor-related white matter tracts, including the corticospinal tract, the cortico-ponto-cerebellar tract, the dorsal spinocerebellar tract, and the dentato-rubro-thalamo-cortical tract. Healthy participants will perform the four weeks of balance training, and DTI will be acquired before and after exercise. The investigators will analyze the DTI-derived parameters of the relevant white matter tracts and analyze the longitudinal changes. The investigators hypothesized that the four weeks of balance training would enhance the integrity of the cerebellar white matter tracts.

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Basic Science
• Official Title: Association Between Balance and the Integrity of Cerebellar White Matter Tracts in a Healthy Population
• Actual Study Start Date: May 24, 2021
• Actual Primary Completion Date: Oct 30, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Balance training A single training group	Behavioral: Balance and Proprioceptive Training; Step-by-step training (5 levels) 30 minute per training 3 times per week Four weeks

Outcome Measures

Primary Outcome Measures

1. Fractional anisotropy of the cerebellar white matter tracts [Four weeks]

   Measurement of the change of DTI-derived parameters before and after balance and proprioceptive training Tracts of interest Corticospinal tract (CST) Cortico-ponto-cerebellar tract (CPCT) Dentato-rubro-thalamo-cortical tract (DRTCT) Dorsal spinocerebellar tract (DSCT) Measurement of DTI-derived parameter Fractional anisotropy (FA) values of the CST, CPCT, DRTCT, and DSCT Units and scoring of the Measurement FA No unit. The measurement ranges from 0 to 1 Higher scores indicate better microstructural integrity.

2. Community Balance & Mobility Scale [Four weeks]

   Performance measure before and after balance and proprioceptive training Measurement 13 domain Unilateral stance, Tandem walking, 180° tandem pivot, Lateral foot scooting, Hopping forward, Crouch and walk, Lateral dodging, Walking & looking, Running with controlled stop, Forward to backward walking, Walk look and carry, Descending stairs, Step-ups x 1 step Scoring of the Measurement No units. The measurement ranges from 0 to 96 Higher scores indicate better postural balance and mobility.

Secondary Outcome Measures

1. Mean diffusivity of the cerebellar white matter tracts [Four weeks]

   Measurement of the change of DTI-derived parameters before and after balance and proprioceptive training Tracts of interest CST CPCT DRTCT DSCT Measurement of DTI-derived parameter Mean Diffusivity (MD) values of the CST, CPCT, DRTCT, and DSCT Units and scoring of the Measurement MD mm^2/second There is no limit on the range (usually ranges 0.00005 - 0.0001 mm^2/second). Higher scores indicate worse microstructural integrity.

2. Tract volume of the cerebellar white matter tracts [Four weeks]

   Measurement of the change of DTI-derived parameters before and after balance and proprioceptive training Tracts of interest CST CPCT DRTCT DSCT Measurement of DTI-derived parameter Tract volume (TV) values of the CST, CPCT, DRTCT, and DSCT Units and scoring of the Measurement TV mm^3 There is no limit on the range. Higher scores indicate better microstructural integrity.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 74 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Mini-mental state examination >=26

• Independent outdoor ambulator

Exclusion Criteria:

• Men/women with any metal implants in their body

• A prior history of psychopathology or a neurological disorders

• A prior history of osteoporosis, advanced osteoarthritis (K-L grade >=3), surgical history of hip or knee arthroplasty

• If any structural abnormalities are detected on their scan

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Yeouido St. Mary's Hospital	Seoul	Yeongdeungpo-gu	Korea, Republic of	07345

Sponsors and Collaborators

• The Catholic University of Korea

Investigators

• Principal Investigator: Youngkook Kim, Ph.D., Yeouido St. Mary's Hospital, College of Medicine, The Catholic University of Korea

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kim JS, Kim SH, Lim SH, Im S, Hong BY, Oh J, Kim Y. Degeneration of the Inferior Cerebellar Peduncle After Middle Cerebral Artery Stroke: Another Perspective on Crossed Cerebellar Diaschisis. Stroke. 2019 Oct;50(10):2700-2707. doi: 10.1161/STROKEAHA.119.025723. Epub 2019 Aug 26.
• Kim Y, Im S, Kim SH, Park GY. Laterality of cerebellar afferent and efferent pathways in a healthy right-handed population: A diffusion tensor imaging study. J Neurosci Res. 2019 May;97(5):582-596. doi: 10.1002/jnr.24378. Epub 2018 Dec 24.
• Kim Y, Kim SH, Kim JS, Hong BY. Modification of Cerebellar Afferent Pathway in the Subacute Phase of Stroke. J Stroke Cerebrovasc Dis. 2018 Sep;27(9):2445-2452. doi: 10.1016/j.jstrokecerebrovasdis.2018.04.039. Epub 2018 May 22.

• Responsible Party: Youngkook Kim, Assistant Professor, The Catholic University of Korea
• ClinicalTrials.gov Identifier: NCT04934319
• Other Study ID Numbers: SC20FISI0152
• First Posted: Jun 22, 2021
• Last Update Posted: Jun 13, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Youngkook Kim, Assistant Professor, The Catholic University of Korea: Balance; Cerebellum; White matter tract; Diffusion Tensor Imaging

Study Results

No Results Posted as of Jun 13, 2022