Trial Outcomes & Findings for tDCS and Glucose Uptake in Leg Muscles (NCT NCT04016844)

Last Updated: 2023-01-25

Results Overview

Participants are walking on a treadmill with tDCS or SHAM, followed by a positron emission tomography (PET) scan to measure glucose uptake in leg muscles. SUV asymmetry indices (AIs) were calculated to determine the magnitude of asymmetry between the more- and less-affected legs with a previously used equation: ((less-affected side - more-affected side)/((0.5) × (less-affected side + more- affected side)) × 100). An AI value ≥ 10% was considered asymmetric.

Recruitment status

COMPLETED

Study phase

Target enrollment

4 participants

Primary outcome timeframe

Six Months

Results posted on

2023-01-25

Participant Flow

All 4 Subjects completed active tDCS first and then SHAM.

Participant milestones

Participant milestones
Measure	tDCS/SHAM Effects on Glucose Uptake in Leg Muscles tDCS Block: The subject will walk for 20 min on a treadmill at a self-selected speed during which time tDCS will be applied to the motor cortex (M1) corresponding to the more-affected leg. transcranial direct current stimulation: A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit. Sham Block: The subject will walk for 20 min on a treadmill at a self-selected speed during which time SHAM will be applied to the motor cortex (M1) corresponding to the more-affected leg. SHAM: In the sham condition, the participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0. The same tDCS device (Soterix) will be used.
Overall Study STARTED	4
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

tDCS and Glucose Uptake in Leg Muscles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	tDCS/SHAM Effects on Glucose Uptake in Leg Muscles n=4 Participants tDCS Block: The subject will walk for 20 min on a treadmill at a self-selected speed during which time tDCS will be applied to the motor cortex (M1) corresponding to the more-affected leg. transcranial direct current stimulation: A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit. Sham Block: The subject will walk for 20 min on a treadmill at a self-selected speed during which time SHAM will be applied to the motor cortex (M1) corresponding to the more-affected leg. SHAM: In the sham condition, the participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0. The same tDCS device (Soterix) will be used.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	45 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 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	0 Participants n=5 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Six Months

Outcome measures

Outcome measures
Measure	tDCS Effects on Glucose Uptake in Leg Muscles n=4 Participants tDCS Block: The subject will walk for 20 min on a treadmill at a self-selected speed during which time tDCS will be applied to the motor cortex (M1) corresponding to the more-affected leg. Transcranial direct current stimulation: A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit.	SHAM Effects on Glucose Uptake in Leg Muscles n=4 Participants SHAM Block: The subject will walk for 20 min on a treadmill at a self-selected speed during which time SHAM stimulation will be applied to the motor cortex (M1) corresponding to the more-affected leg. SHAM stimulation: A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit.The participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0.
Glucose Uptake in Leg Muscles	6.3 Percentage (%) Standard Deviation 6.2	16.4 Percentage (%) Standard Deviation 13.6

SECONDARY outcome

Timeframe: Six Months

Ratings of perceived exertion (RPE) will be recorded with the modified Borg 10-point scale (Borg, 1982). The subjects will be instructed to estimate their effort during walking. The scale will be anchored so that 0 denotes the resting state and 10 represents the strongest effort they are able to perform.

Outcome measures

Outcome measures
Measure	tDCS Effects on Glucose Uptake in Leg Muscles n=4 Participants tDCS Block: The subject will walk for 20 min on a treadmill at a self-selected speed during which time tDCS will be applied to the motor cortex (M1) corresponding to the more-affected leg. Transcranial direct current stimulation: A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit.	SHAM Effects on Glucose Uptake in Leg Muscles n=4 Participants SHAM Block: The subject will walk for 20 min on a treadmill at a self-selected speed during which time SHAM stimulation will be applied to the motor cortex (M1) corresponding to the more-affected leg. SHAM stimulation: A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit.The participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0.
Ratings of Perceived Exertion (RPE)	6 units on a scale Standard Deviation 4	6 units on a scale Standard Deviation 5

Adverse Events

tDCS/SHAM Effects on Glucose Uptake in Leg Muscles

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

Dr.Thorsten Rudroff

University of Iowa

Phone: 17205323701

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place