Trial Outcomes & Findings for Deep Brain Stimulation Effects on Weight Change and Metabolic Rate (NCT NCT01933113)
NCT ID: NCT01933113
Last Updated: 2025-10-27
Results Overview
Metabolic rate of subjects will be measured while at Pennington Biomedical Research Center. Percentage of change in these parameters will be measured.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
One week of testing for each subject.
Results posted on
2025-10-27
Participant Flow
Participant milestones
| Measure |
Single arm
DBS of the LHA
Deep Brain Stimulation of the Lateral Hypothalamic Area
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Single arm
DBS of the LHA
Deep Brain Stimulation of the Lateral Hypothalamic Area
|
|---|---|
|
Overall Study
Fractured nonfunctioning lead.
|
1
|
Baseline Characteristics
One subject was withdrawn due to a lead breakage and medical instability pertaining to an unrelated abdominal infection.
Baseline characteristics by cohort
| Measure |
Single arm
n=3 Participants
DBS of the LHA
Deep Brain Stimulation of the Lateral Hypothalamic Area
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants • One subject was withdrawn due to a lead breakage and medical instability pertaining to an unrelated abdominal infection.
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants • One subject was withdrawn due to a lead breakage and medical instability pertaining to an unrelated abdominal infection.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
|
BMI
|
2 Participants
n=2 Participants • One subject was withdrawn due to lead fracture and unrelated abdominal infection leaving 2 evaluable subjects
|
PRIMARY outcome
Timeframe: One week of testing for each subject.Metabolic rate of subjects will be measured while at Pennington Biomedical Research Center. Percentage of change in these parameters will be measured.
Outcome measures
| Measure |
Single arm
n=2 Participants
DBS of the LHA
Deep Brain Stimulation of the Lateral Hypothalamic Area
|
|---|---|
|
Change in Metabolic Rate
Sleep Energy Expenditure (SEE)
|
7.6 percentage of increase in REM and SEE
Standard Deviation 3.9598
|
|
Change in Metabolic Rate
Resting Metabolic Rate (RMR)
|
18 percentage of increase in REM and SEE
Standard Deviation 2.8284
|
Adverse Events
Single arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place