tDCS and Glucose Uptake in Leg Muscles

NCT04016844 | Completed Results FDA Device

• 1 other identifier: 201905825
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Multiple Scerosis; PET; tDCS

Outcome Measures

Primary Outcomes (1)

• Glucose Uptake in Leg Muscles

  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.

  Six Months

Secondary Outcomes (1)

• Ratings of Perceived Exertion (RPE)

  Six Months

Study Arms (1)

tDCS first then SHAM effects on glucose uptake in leg muscles

EXPERIMENTAL

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. 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: transcranial direct current stimulation or SHAM

Interventions

transcranial direct current stimulation or SHAM DEVICE

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. 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.

tDCS first then SHAM effects on glucose uptake in leg muscles

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• medically diagnosed with Multiple Sclerosis (MS)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Results Point of Contact

• Title: Dr.Thorsten Rudroff
• Organization: University of Iowa

thorsten-rudroff@uiowa.edu

17205323701

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will receive tDCS in one session and SHAM in the other session.

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 12, 2019
• Study Start: December 6, 2019
• Primary Completion: October 1, 2020
• Study Completion: October 1, 2020
• Last Updated: January 25, 2023
• Results First Posted: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)