Trial Outcomes & Findings for Glucose and Non-Invasive Brain Stimulation (NCT NCT04031404)
NCT ID: NCT04031404
Last Updated: 2021-09-27
Results Overview
Change in MEP over time to indicate changes in motor cortex excitability
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.
Results posted on
2021-09-27
Participant Flow
Participant milestones
| Measure |
Glucose Drink Followed by Placebo
Participants will consume the glucose drink at session 1, then they will consume the placebo (water) at session 2.
Single-pulse TMS: Single-pulse transcranial magnetic stimulation (TMS) on the motor cortex will lead to a twitch in the target muscle and evoke a motor-evoked potential (MEP) measured by electromyography (EMG).
|
Placebo Followed by Glucose Drink
Participants will consume the placebo (water) at session 1, then they will consume the glucose drink at session 2.
Single-pulse TMS: Single-pulse transcranial magnetic stimulation (TMS) on the motor cortex will lead to a twitch in the target muscle and evoke a motor-evoked potential (MEP) measured by electromyography (EMG).
|
|---|---|---|
|
Baseline
STARTED
|
10
|
13
|
|
Baseline
COMPLETED
|
8
|
8
|
|
Baseline
NOT COMPLETED
|
2
|
5
|
|
Pre-randomization
STARTED
|
8
|
8
|
|
Pre-randomization
COMPLETED
|
6
|
5
|
|
Pre-randomization
NOT COMPLETED
|
2
|
3
|
|
First Drink Visit
STARTED
|
6
|
5
|
|
First Drink Visit
COMPLETED
|
6
|
5
|
|
First Drink Visit
NOT COMPLETED
|
0
|
0
|
|
Washout (5 Day Min)
STARTED
|
6
|
5
|
|
Washout (5 Day Min)
COMPLETED
|
5
|
5
|
|
Washout (5 Day Min)
NOT COMPLETED
|
1
|
0
|
|
Second Drink Visit
STARTED
|
5
|
5
|
|
Second Drink Visit
COMPLETED
|
5
|
5
|
|
Second Drink Visit
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
Glucose Drink Followed by Placebo
Participants will consume the glucose drink at session 1, then they will consume the placebo (water) at session 2.
Single-pulse TMS: Single-pulse transcranial magnetic stimulation (TMS) on the motor cortex will lead to a twitch in the target muscle and evoke a motor-evoked potential (MEP) measured by electromyography (EMG).
|
Placebo Followed by Glucose Drink
Participants will consume the placebo (water) at session 1, then they will consume the glucose drink at session 2.
Single-pulse TMS: Single-pulse transcranial magnetic stimulation (TMS) on the motor cortex will lead to a twitch in the target muscle and evoke a motor-evoked potential (MEP) measured by electromyography (EMG).
|
|---|---|---|
|
Baseline
Lost to Follow-up
|
0
|
1
|
|
Baseline
Did not meet full inclusion/exclusion.
|
2
|
4
|
|
Pre-randomization
Withdrawn for COVID19 precautions
|
1
|
3
|
|
Pre-randomization
Disqualified by TMS safety screening
|
1
|
0
|
|
Washout (5 Day Min)
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Glucose and Non-Invasive Brain Stimulation
Baseline characteristics by cohort
| Measure |
All Participants
n=23 Participants
Participants will consume the glucose drink at session 1, then they will consume the placebo (water) at session 2, or vice versa.
Single-pulse TMS: Single-pulse transcranial magnetic stimulation (TMS) on the motor cortex will lead to a twitch in the target muscle and evoke a motor-evoked potential (MEP) measured by electromyography (EMG).
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
24.64 years
STANDARD_DEVIATION 10.49 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.Population: From the 10 participants who completed, 3 were excluded from the analysis due to technical reasons. Two participants had to end their glucose visits early due to scheduling conflicts. The reported N below is adjusted where appropriate.
Change in MEP over time to indicate changes in motor cortex excitability
Outcome measures
| Measure |
MEP After Glucose Drink
n=7 Participants
Participants receive TMS to motor cortex following consumption of a 75 g glucose drink (\~300 mL).
|
MEP After Placebo Drink
n=7 Participants
Participants receive TMS to motor cortex following consumption of a water control (\~300 mL).
|
|---|---|---|
|
Motor Evoked Potential (MEP)
MEP change (0 min vs pre-drink)
|
0.14 log10(Post uV/Baseline uV)
Standard Error 0.15
|
-0.25 log10(Post uV/Baseline uV)
Standard Error 0.07
|
|
Motor Evoked Potential (MEP)
MEP change (30 min vs pre-drink)
|
-0.02 log10(Post uV/Baseline uV)
Standard Error 0.19
|
-0.12 log10(Post uV/Baseline uV)
Standard Error 0.11
|
|
Motor Evoked Potential (MEP)
MEP change (60 min vs pre-drink)
|
-0.08 log10(Post uV/Baseline uV)
Standard Error 0.14
|
-0.33 log10(Post uV/Baseline uV)
Standard Error 0.10
|
|
Motor Evoked Potential (MEP)
MEP change (120 min vs pre-drink)
|
-0.05 log10(Post uV/Baseline uV)
Standard Error 0.16
|
-0.25 log10(Post uV/Baseline uV)
Standard Error 0.09
|
|
Motor Evoked Potential (MEP)
MEP change (180 min vs pre-drink)
|
-0.21 log10(Post uV/Baseline uV)
Standard Error 0.18
|
-0.18 log10(Post uV/Baseline uV)
Standard Error 0.10
|
PRIMARY outcome
Timeframe: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.Population: From the 10 participants who completed, 3 were excluded from the analysis due to technical reasons. Two participants had to end their glucose visits early due to scheduling conflicts. The reported N below is adjusted where appropriate.
The TMS Evoked Potential (TEP) is the difference in microvolts from 25 milliseconds after a TMS pulse versus pre-TMS such that greater values indicate greater motor cortex excitability. The measure of the change in TEP over time since either glucose or water was consumed approximates a z-distribution with a range of -20 to 20 with central distribution measures of zero. TEPs were source localized and reported using a pseudo-neural activity index (PNAI) expressing source activation in relation to pre-TMS pulse trial baseline. The difference in the source peaks corresponding to the early P25 component have been reported as differences from baseline. Higher values indicate greater cortical excitation, consistent with the study hypothesis.
Outcome measures
| Measure |
MEP After Glucose Drink
n=7 Participants
Participants receive TMS to motor cortex following consumption of a 75 g glucose drink (\~300 mL).
|
MEP After Placebo Drink
n=7 Participants
Participants receive TMS to motor cortex following consumption of a water control (\~300 mL).
|
|---|---|---|
|
TMS Evoked Potential (TEP)
TEP change (P25: 0 min vs pre-drink)
|
-0.04 z-score
Standard Error 0.08
|
0.28 z-score
Standard Error 0.16
|
|
TMS Evoked Potential (TEP)
TEP change (P25: 30 min vs pre-drink)
|
-0.11 z-score
Standard Error 0.11
|
0.024 z-score
Standard Error 0.05
|
|
TMS Evoked Potential (TEP)
TEP change (P25: 60 min vs pre-drink)
|
-0.16 z-score
Standard Error 0.11
|
0.30 z-score
Standard Error 0.06
|
|
TMS Evoked Potential (TEP)
TEP change (P25: 120 min vs pre-drink)
|
-0.16 z-score
Standard Error 0.12
|
0.24 z-score
Standard Error 0.07
|
|
TMS Evoked Potential (TEP)
TEP change (P25: 180 min vs pre-drink)
|
0.08 z-score
Standard Error 0.08
|
0.02 z-score
Standard Error 0.15
|
SECONDARY outcome
Timeframe: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.Population: From the 10 participants who completed, one was excluded from the analysis due to technical reasons. Two participants had to end their glucose visits early due to scheduling conflicts. The reported N below is adjusted where appropriate.
Electroencephalography will be used to measure the change in lateralized alpha asymmetry (10-12 Hz electrical activity) over time
Outcome measures
| Measure |
MEP After Glucose Drink
n=9 Participants
Participants receive TMS to motor cortex following consumption of a 75 g glucose drink (\~300 mL).
|
MEP After Placebo Drink
n=9 Participants
Participants receive TMS to motor cortex following consumption of a water control (\~300 mL).
|
|---|---|---|
|
EEG Measure of Alpha Asymmetry Oscillations
Alpha Asymm. Change (0 min vs Baseline)
|
0.15 10*log10(Right Alpha/Left Alpha) (uV)
Standard Error 0.15
|
0.59 10*log10(Right Alpha/Left Alpha) (uV)
Standard Error 0.45
|
|
EEG Measure of Alpha Asymmetry Oscillations
Alpha Asymm. Change (30 min vs Baseline)
|
-0.01 10*log10(Right Alpha/Left Alpha) (uV)
Standard Error 0.20
|
0.42 10*log10(Right Alpha/Left Alpha) (uV)
Standard Error 0.42
|
|
EEG Measure of Alpha Asymmetry Oscillations
Alpha Asymm. Change (60 min vs Baseline)
|
0.14 10*log10(Right Alpha/Left Alpha) (uV)
Standard Error 0.22
|
0.19 10*log10(Right Alpha/Left Alpha) (uV)
Standard Error 0.25
|
|
EEG Measure of Alpha Asymmetry Oscillations
Alpha Asymm. Change (120 min vs Baseline)
|
0.18 10*log10(Right Alpha/Left Alpha) (uV)
Standard Error 0.22
|
0.33 10*log10(Right Alpha/Left Alpha) (uV)
Standard Error 0.22
|
|
EEG Measure of Alpha Asymmetry Oscillations
Alpha Asymm. Change (180 min vs Baseline)
|
0.18 10*log10(Right Alpha/Left Alpha) (uV)
Standard Error 0.33
|
0.28 10*log10(Right Alpha/Left Alpha) (uV)
Standard Error 0.33
|
SECONDARY outcome
Timeframe: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.Population: From the 10 participants who completed, one was excluded from the analysis due to technical reasons. Two participants had to end their glucose visits early due to scheduling conflicts. The reported N below is adjusted where appropriate.
Electroencephalography will be used to measure the change in frontal midline theta power (5-8 Hz electrical activity) over time
Outcome measures
| Measure |
MEP After Glucose Drink
n=9 Participants
Participants receive TMS to motor cortex following consumption of a 75 g glucose drink (\~300 mL).
|
MEP After Placebo Drink
n=9 Participants
Participants receive TMS to motor cortex following consumption of a water control (\~300 mL).
|
|---|---|---|
|
EEG Measure of Frontal Midline Theta Oscillations
Theta Power Change (0 min vs Baseline)
|
0.12 10*log10(Post uV/Baseline uV)
Standard Error 0.34
|
0.33 10*log10(Post uV/Baseline uV)
Standard Error 0.28
|
|
EEG Measure of Frontal Midline Theta Oscillations
Theta Power Change (30 min vs Baseline)
|
0.56 10*log10(Post uV/Baseline uV)
Standard Error 0.25
|
0.57 10*log10(Post uV/Baseline uV)
Standard Error 0.27
|
|
EEG Measure of Frontal Midline Theta Oscillations
Theta Power Change (60 min vs Baseline)
|
0.94 10*log10(Post uV/Baseline uV)
Standard Error 0.29
|
1.15 10*log10(Post uV/Baseline uV)
Standard Error 0.32
|
|
EEG Measure of Frontal Midline Theta Oscillations
Theta Power Change (120 min vs Baseline)
|
0.36 10*log10(Post uV/Baseline uV)
Standard Error 0.26
|
1.21 10*log10(Post uV/Baseline uV)
Standard Error 0.45
|
|
EEG Measure of Frontal Midline Theta Oscillations
Theta Power Change (180 min vs Baseline)
|
1.48 10*log10(Post uV/Baseline uV)
Standard Error 0.32
|
0.72 10*log10(Post uV/Baseline uV)
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Measurements will be taken before the administration of the drink, as well as 0, 30, 60, 120, and 180 minutes after the administration of the drink.Population: From the 10 participants who completed, one was excluded from the analysis due to technical reasons. Two participants had to end their glucose visits early due to scheduling conflicts. The reported N below is adjusted where appropriate.
This outcome will analyze the change in accuracy in a computerized working memory task over time. During the task, subjects will be presented with an array of colored squares. Then, they will need to hold this array in mind during a delay period. Finally, participants will be tested on their memory of the array by responding whether a presented color is the same or different as the corresponding square in the first array. Participants' accuracy will be expressed as the percentage of correct responses (from 0% correct responses to 100% correct responses). An accuracy rate of 50% indicates that the participant is performing at the same accuracy level as random chance.
Outcome measures
| Measure |
MEP After Glucose Drink
n=9 Participants
Participants receive TMS to motor cortex following consumption of a 75 g glucose drink (\~300 mL).
|
MEP After Placebo Drink
n=9 Participants
Participants receive TMS to motor cortex following consumption of a water control (\~300 mL).
|
|---|---|---|
|
Working Memory Task Accuracy
WM Accuracy (0 min vs Baseline)
|
1.02 Ratio of correct responses
Standard Error 0.03
|
0.97 Ratio of correct responses
Standard Error 0.03
|
|
Working Memory Task Accuracy
WM Accuracy (30 min vs Baseline)
|
1.02 Ratio of correct responses
Standard Error 0.02
|
0.99 Ratio of correct responses
Standard Error 0.03
|
|
Working Memory Task Accuracy
WM Accuracy (60 min vs Baseline)
|
1.06 Ratio of correct responses
Standard Error 0.02
|
1.01 Ratio of correct responses
Standard Error 0.03
|
|
Working Memory Task Accuracy
WM Accuracy (120 min vs Baseline)
|
1.05 Ratio of correct responses
Standard Error 0.03
|
1.02 Ratio of correct responses
Standard Error 0.03
|
|
Working Memory Task Accuracy
WM Accuracy (180 min vs Baseline)
|
1.03 Ratio of correct responses
Standard Error 0.03
|
1.03 Ratio of correct responses
Standard Error 0.03
|
Adverse Events
TMS-EEG After Glucose Drink
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
TMS-EEG After Placebo Drink
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
TMS-EEG After Glucose Drink
n=11 participants at risk
Participants receive TMS to motor cortex following consumption of a 75 g glucose drink (\~300 mL).
During every session, participants receive single pulse TMS to the motor cortex, and complete EEG recordings and a working memory task at several time points.
|
TMS-EEG After Placebo Drink
n=10 participants at risk
Participants receive TMS to motor cortex following consumption of a water control drink (\~300 mL).
During every session, participants receive single pulse TMS to the motor cortex, and complete EEG recordings and a working memory task at several time points.
|
|---|---|---|
|
Ear and labyrinth disorders
Ringing or buzzing noise
|
18.2%
2/11 • Number of events 2 • Up to 2 months per participant
|
0.00%
0/10 • Up to 2 months per participant
|
|
General disorders
Dizziness
|
27.3%
3/11 • Number of events 3 • Up to 2 months per participant
|
10.0%
1/10 • Number of events 1 • Up to 2 months per participant
|
|
General disorders
Sleepiness
|
72.7%
8/11 • Number of events 8 • Up to 2 months per participant
|
50.0%
5/10 • Number of events 5 • Up to 2 months per participant
|
|
General disorders
Trouble concentrating
|
36.4%
4/11 • Number of events 4 • Up to 2 months per participant
|
20.0%
2/10 • Number of events 2 • Up to 2 months per participant
|
|
General disorders
Headache
|
45.5%
5/11 • Number of events 5 • Up to 2 months per participant
|
30.0%
3/10 • Number of events 3 • Up to 2 months per participant
|
|
Skin and subcutaneous tissue disorders
Itching
|
45.5%
5/11 • Number of events 5 • Up to 2 months per participant
|
40.0%
4/10 • Number of events 4 • Up to 2 months per participant
|
|
Skin and subcutaneous tissue disorders
Local redness
|
36.4%
4/11 • Number of events 4 • Up to 2 months per participant
|
10.0%
1/10 • Number of events 1 • Up to 2 months per participant
|
|
Skin and subcutaneous tissue disorders
Scalp pain
|
27.3%
3/11 • Number of events 3 • Up to 2 months per participant
|
30.0%
3/10 • Number of events 3 • Up to 2 months per participant
|
|
Skin and subcutaneous tissue disorders
Tingling
|
18.2%
2/11 • Number of events 2 • Up to 2 months per participant
|
10.0%
1/10 • Number of events 1 • Up to 2 months per participant
|
|
Psychiatric disorders
Worsening mood
|
45.5%
5/11 • Number of events 5 • Up to 2 months per participant
|
20.0%
2/10 • Number of events 2 • Up to 2 months per participant
|
|
General disorders
Flickering lights
|
0.00%
0/11 • Up to 2 months per participant
|
0.00%
0/10 • Up to 2 months per participant
|
|
Skin and subcutaneous tissue disorders
Burning sensation
|
0.00%
0/11 • Up to 2 months per participant
|
0.00%
0/10 • Up to 2 months per participant
|
|
Skin and subcutaneous tissue disorders
Neck pain
|
0.00%
0/11 • Up to 2 months per participant
|
0.00%
0/10 • Up to 2 months per participant
|
Additional Information
Rachel B. Force, PhD
University of North Carolina at Chapel Hill
Phone: 9199669929
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place