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tDCS and Glucose Uptake in Leg Muscles

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ClinicalTrials.gov Identifier: NCT04016844
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 15, 2019
Sponsor:
Information provided by (Responsible Party):
Thorsten Rudroff, University of Iowa

Brief Summary:

This study is to examine the efficacy of tDCS to improving walking in people with Multiple Sclerosis (PwMS).

Our study compromises 1 group of subjects with MS which will attend the lab for three sessions. In the first session, subjects will be consented, complete the Patient Determined Disease Steps (PDDS), the Fatigue Severity Scale (FSS), and maximal voluntary contractions (MVCs) of the right and left knee extensors and flexors to determine the more-affected leg. The second and third sessions will involve whole-body FDG PET imaging. During each of these sessions, the subject will walk for 20 min on a treadmill at a self-selected speed during which time tDCS or SHAM, in a blinded manner, will be applied to the motor cortex (M1) corresponding to the more-affected leg. Approximately 2 minutes into the walking, [18F]fluorodeoxyglucose (FDG) will be administered by IV injection. Immediately after the walking is completed, the subject will be positioned in the PET/CT scanner and a whole body (top of head to toes) PET/CT scan will be acquired for the evaluation of glucose metabolism in the brain, spine, and lower extremities. The third session will be identical to the second session with the exception that the opposite condition (tDCS or SHAM) will be used.


Condition or disease Intervention/treatment Phase
Multiple Sclerosis Device: transcranial direct current stimulation Device: SHAM Not Applicable

Detailed Description:

Prospective participants, men and women with MS, will be recruited. The plan is to enroll up to 30 to get 20 evaluable subjects. To accomplish this study, all participants will need to complete 3 sessions. The first session at the INPL and sessions 2 and 3 at PET Imaging Center (0911ZJPP) and the PET Imaging lab in Pappajohn Biomedical Discovery Building. Session 2 and 3 are separated by 5-8 days. The duration of each session will be approximately 120 minutes. We expect data collection to last 6 months.

In the first session, subjects will be consented, complete the PDDS, the Fatigue Severity Scale (FSS), and maximal voluntary contractions (MVCs) of the right and left knee extensors and flexors to determine the more-affected leg. When leg strength difference is less than 10%, the more affected side will be based on self-report. The second and the third sessions will involve 20 min walking on a treadmill at a self-selected speed during which time tDCS or SHAM will be applied to the motor cortex (M1) corresponding to the more-affected leg and [18F]fluorodeoxyglucose will be administered. At the end of the walking period, the subject will be imaged on a PET/CT scanner from top of head to toes.

Prior to sessions 2 and 3, all subjects will be asked to fast (water and medication can be taken during this time) for a minimum of 6 hours prior to the FDG administration. In addition, the blood glucose level will be checked (via Accuchek) prior to FDG administration and the level must be equal to or less than 200 mg/dL in order to proceed with the FDG administration on that day. At the beginning of session 2 and 3, the subject will be weighed and height measured, have a blood glucose level determined via Accuchek as described above, undergo a urine pregnancy test if the subject is of child-bearing potential, and have an IV catheter inserted for FDG administration. The subject will then be moved to the PET Scanner area in Pappajohn Biomedical Discovery Building. The subject will be asked to use the restroom prior to walking on the treadmill. 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 participant will receive tDCS or SHAM throughout the walking (i.e., for 20 min). In the tDCS trial, the intensity will start at 0 mA and will increase to 3 mA over the first 30 seconds. In the sham condition, the participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0.

Two min into the walking test on the treadmill, 10 mCi of [18F]-FDG will be injected IV. Then, the walking test continues until 20 min is reached. When the walking test is completed, the tDCS device will be removed and the subject will be positioned in the PET/CT scanner and a whole body (top of head to toes) PET/CT scan will be acquired.

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

No long-term follow-up will be done.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Participants will receive tDCS in one session and SHAM in the other session.
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Transcranial Direct Current Stimulation to Reduce Asymmetric Glucose Uptake in Leg Muscles of Persons With Multiple Sclerosis
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: tDCS 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.
Device: 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.

Placebo Comparator: Sham effects on glucose uptake in leg muscles
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.
Device: 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.




Primary Outcome Measures :
  1. Glucose uptake in leg muscles [ Time Frame: Through study completion, on average 1 year ]
    Participants are walking on a treadmill with tDCS or SHAM, followed by PET scan to measure glucose uptake in leg muscles.


Secondary Outcome Measures :
  1. Ratings of perceived exertion (RPE) [ Time Frame: Through study completion, on average 1 year ]
    Ratings of perceived exertion (RPE) will be recorded with the modified Borg 10-point scale (Borg, 1982). The subjects will be instructed to estimate the effort during walking. The scale will be anchored so that 0 denotes the resting state and 10 represents the strongest effort.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • medically diagnosed with Multiple Sclerosis (MS)
  • 18-70 yrs. of age, moderate disability (Patient Determined Disease Steps (PDDS) core 2-6)
  • Self-reported differences in function between legs, able to walk for 20 min.

Exclusion Criteria:

  • MS relapse within last 60 days
  • inability to fast for 6 hours
  • hyperglycemia (fasting blood sugar > 200 mg/dL)
  • insulin-dependent diabetes
  • high risk for cardiovascular disease (ACSM risk classification)
  • changes in disease-modifying medications within last 45 days
  • concurrent neurological/neuromuscular disease
  • hospitalization within last 90 days
  • diagnosed depression
  • inability to understand/sign informed consent, pregnant, history of seizure disorders (or on medications known to lower seizure threshold)
  • hydrocephalus.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016844


Contacts
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Contact: Thorsten Rudroff 319467 ext 319467 thorsten-rudroff@uiowa.edu

Locations
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United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa

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Responsible Party: Thorsten Rudroff, Principal Investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT04016844     History of Changes
Other Study ID Numbers: 201905825
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Thorsten Rudroff, University of Iowa:
Multiple Scerosis
PET
tDCS

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases