UMIN-ICDS Clinical Trial

Public title

Prospective Study of Body Weight and Energy Balance in People with Parkinson's Disease Before and After Initiation of Device-Aided Therapies

Acronym

Prospective Study of Body Weight and Energy Balance in People with Parkinson's Disease Before and After Initiation of Device-Aided Therapies

Scientific Title

Prospective Study of Body Weight and Energy Balance in People with Parkinson's Disease Before and After Initiation of Device-Aided Therapies

Scientific Title:Acronym

Prospective Study of Body Weight and Energy Balance in People with Parkinson's Disease Before and After Initiation of Device-Aided Therapies

Region

Japan

Condition

Parkinson's disease

Classification by specialty

Neurology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Parkinson's disease (PD) is associated with progressive body weight loss in approximately half of patients over the course of the disease, and patients with marked weight loss tend to experience greater deterioration in motor symptoms and poorer clinical outcomes. In contrast, weight gain has been consistently reported following deep brain stimulation (DBS), a device-aided therapy (DAT) for advanced PD. Elucidating the mechanisms underlying these changes and establishing effective strategies to maintain an appropriate body weight are therefore important clinical challenges.

The aim of this study is to investigate the factors contributing to body weight loss in advanced PD and to body weight changes following the initiation of device-aided therapies (DAT), including DBS and continuous subcutaneous foslevodopa/foscarbidopa infusion (CSCI), with a particular focus on energy metabolism.

Basic objectives2

Others

Basic objectives -Others

Patients with PD who are scheduled to undergo DAT based on routine clinical decision-making will be enrolled. Various parameters related to energy metabolism will be assessed before DAT initiation and again 1 year later. In a subset of participants, total energy expenditure (TEE) will be measured using the doubly labeled water (DLW) method. Data obtained from this subset will be used to estimate TEE in the overall study population for subsequent analyses of energy metabolism.
In addition, this study aims to clarify the mechanisms underlying body weight changes by comparing two DAT modalities, DBS and CSCI. Furthermore, if participants who were initially scheduled to undergo DAT ultimately do not receive device-aided therapy and are instead managed with best medical therapy (BMT), they will be included as the BMT group and compared with the DBS and CSCI groups.

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Change in body weight from baseline to 1 year in the DBS, CSCI, and BMT groups.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

30

years-old

<=

Age-upper limit

75

years-old

>=

Gender

Male and Female

Key inclusion criteria

Patients with PD who attend the Department of Neurology, Juntendo University Hospital, between the date of study approval and March 31, 2028, and who are scheduled to undergo either subthalamic nucleus deep brain stimulation (STN-DBS) implantation or initiation of continuous subcutaneous carbidopa/levodopa infusion (CSCI) within 3 months at the same institution will be eligible for enrollment.
Inclusion Criteria
1. Age between 30 and 75 years at the time of obtaining informed consent.
2. Diagnosed with clinically established PD according to the Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's Disease.
3. Able to provide written informed consent voluntarily after receiving a full explanation of the study and demonstrating adequate understanding of its contents.

Key exclusion criteria

Exclusion Criteria
Patients with severe renal, hepatic, cardiac, or respiratory dysfunction.
Patients with poorly controlled diabetes mellitus.
Pregnant or breastfeeding women.
Patients who are unable to undergo the examinations required for this study.
Patients who are considered unsuitable for participation in this study by the principal investigator.

Target sample size

120

Name of lead principal investigator

1st name	Taku
Middle name
Last name	Hatano

Organization

Juntendo University Hospital

Division name

Neurology

Zip code

113-8421

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL

0338133111

Email

h-amano@juntendo.ac.jp

Name of contact person

1st name	Haruka
Middle name
Last name	Takeshige-amano

Organization

Juntendo University Hospital

Division name

Department of Neurology

Zip code

113-8421

Address

2-1-1, Hongo, Bunkyo-ku, Tokyo

TEL

0338133111

Homepage URL

Email

h-amano@juntendo.ac.jp

Institute

Juntendo University

Institute

Department

Personal name

Organization

Japan Science and Technology Agency

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Japan Agency for Medical Research and Development
Japan Society for the Promotion of Science

Organization

Juntendo University Hospital Clinical Research and Trial Center

Address

3-1-3,Hongo,Bunkyo-ku,Tokyo

Tel

03-3814-5672

Email

hongo-rinri@juntendo.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

07

Month

10

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Preinitiation

Date of protocol fixation

2026

Year

05

Month

01

Day

Date of IRB

2026

Year

06

Month

23

Day

Anticipated trial start date

2026

Year

07

Month

13

Day

Last follow-up date

2030

Year

09

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

In addition to the common assessments, this study will include a DLW group, in which the doubly labeled water (DLW) method is performed, and a non-DLW group, in which only the common assessments are conducted. In both groups, demographic and clinical characteristics, physical examination findings, vital signs, indirect calorimetry, physical activity monitoring, dietary assessment, body composition, and swallowing function will be evaluated before DAT initiation (baseline) and again at the 1-year follow-up.

Registered date

2026

Year

06

Month

29

Day

Last modified on

2026

Year

06

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071017