Cerebral Blood Flow and tDCS

NCT04033133 | Completed

• 1 other identifier: 201905826
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

With this study, the investigators will substantiate if regional cerebral blood flow (CBF) is affected by tDCS, assess the amount of CBF change in relation to different currents, and measure differences in regional CBF under stimulation reactivity between healthy subjects and people with Multiple Sclerosis (PwMS)using Water O-15 PET (Water Oxygen-15 Positron EmissionTomography) imaging. The objective is to investigate the changes in regional CBF after transcranial direct current stimulation (tDCS) at different intensities (1 mA, 2 mA, 3 mA, 4 mA) in healthy subjects and PwMS. The design is a cross-sectional proof of principle study in 10 healthy subjects and 10 PwMS. Relative regional brain CBF (rCBF) will be analyzed semi-quantitatively using voxel-wise and region of interest-based approaches. Changes in CBF associated with tDCS-application will be calculated with a general linear model in a ramp function of the task-specific rCBF, according to previous work in our group using a glucose analogue. Exploratory statistical testing will be done using a paired samples t-test between task and rest conditions and unpaired t-tests between PwMS and healthy controls at the same intensities. With this study the investigators will be able to dose-dependently measure real-time rCBF changes after non-invasively stimulating the superficial parts of the dorsolateral prefrontal cortex (DLPFC), a commonly used target in therapeutic tDCS applications. This will provide further insight into whether tDCS is capable of inducing changes in rCBF.

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; tDCS; Cerebral Blood Flow

Outcome Measures

Primary Outcomes (1)

• Cerebral Blood Flow

  Cerebral Blood flow will be measured while subjects undergo tDCS at different intensities in the PET scanner.

  Through study completion, an average of 1 year

Study Arms (2)

Multiple Sclerosis

EXPERIMENTAL

People with MS get tDCS with different intensities.

Device: tDCS

Healthy Subjects

ACTIVE COMPARATOR

Healthy subjects get tDCS with different intensities.

Device: tDCS

Interventions

tDCS DEVICE

Subjects will get tDCS at intensities of 0, 1, 2, 3, and 4 mA.

Healthy Subjects; Multiple Sclerosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of multiple sclerosis by a neurologist
• No change in MS-specific medication (disease modification drugs) in the last three months
• Healthy enough to complete the protocol based on information obtained from a clinical exam and past medical history.
• An expanded disability status scale (EDSS) below 5.5
• Comprehension of the protocol as indicated by an ability to respond to questions about the study after reading the consent form.
• Able to use and be contacted by telephone
• Able to speak, read, and understand English, and complete a questionnaire in English
• Body mass index \<30 kg/m2

You may not qualify if:

• A relapse of disease symptoms in the last three months
• History / presence of secondary conditions such as seizure disorders (or on medications known to lower seizure threshold), hydrocephalus, diabetes mellitus, or claustrophobia
• Alcohol dependence or abuse (\>2 drinks/day), or present history (last six months) of drug abuse
• History of significant traumatic brain injury or hydrocephalus
• Currently pregnant
• Recent hospitalization (within the last 3 months) or enforced bed rest/sedentary state
• Claustrophobia
• A subject will be excluded if he/she has a contraindication to Magnetic Resonance scanning, e.g., implanted metal clips or wires, which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field.
• Examples include:
• Aneurysm clip
• Implanted neural stimulator
• Implanted cardiac pacemaker or autodefibrillator
• Cochlear implant
• Ocular foreign body (e.g., metal shavings)
• Any implanted device (pumps, infusion devices, etc.)

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

Department of Health and Human Physiology

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: People with Multiple Sclerosis and healthy controls will receive tDCS at different intensities while in the PET scanner.

Study Record Dates

• First Submitted: July 23, 2019
• First Posted: July 25, 2019
• Study Start: December 20, 2019
• Primary Completion: August 15, 2020
• Study Completion: August 15, 2020
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)