tDCS to Lower Neuropathic Pain and Fatigue in People With Multiple Sclerosis

NCT03870048 | Completed Results FDA Device

• 1 other identifier: 201812729
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of transcranial direct current stimulation (tDCS) on neuropathic pain and fatigue in people with MS. The investigators will conduct tDCS or sham on 5 consecutive days. They will evaluate pain and fatigue with specific questionnaires and measure fatigability with an isokinetic device. The research question is whether tDCS can lessen neuropathic pain and increase fatigue resistance in people with MS. It is hypothesized, that less neuropathic pain and increased fatigue resistance after the tDCS sessions.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Neuropathic Pain Questionnaire (NPQ) Contains 12 Items.

  The participant is asked to use items to rate their pain as it usually feels. They have to indicate a number which represents their pain on each scale. For example, if someone has no burning pain, the person would rate the first item "0". If the person has the worst burning pain imaginable, he/she would rate it "100". If neither of those fits his/her pain because it is in between, the participant has to choose a number which fits his/her pain.

  2 Months

Secondary Outcomes (1)

• Fatigue Severity Scale (FSS) Contains Nine Statements That Attempt to Explore Severity of Fatigue Symptoms.

  2 Months

Study Arms (1)

All Study Participants/tDCS or SHAM

EXPERIMENTAL

tDCS Block: The participant will receive tDCS for 20 min at an intensity of 2 mA while seated comfortably and quietly in a room. The intensity will start at 0 mA and will be incrementally increased to 2mA over the initial 30 seconds. At the 19:30 minute time point, the current will gradually be reduced from 2 mA to 0 mA. Sham block: Identical to the tDCS block, except the participants will only receive the initial 30 seconds of ramp-up, after which the current will be set to 0 for the remainder of the 20 minutes.

Device: transcranial direct current stimulation

Interventions

transcranial direct current stimulation 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.

All Study Participants/tDCS or SHAM

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
• yrs. of age, moderate disability (Patient Determined Disease Steps (PDDS) core 2-6)
• Self-reported differences in function between legs
• Able to walk for 6 min
• Presenting with chronic, drug-resistant, neuropathic pain.

You may not qualify if:

• Relapse within last 60 days
• 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.

Sponsors & Collaborators

• University of Iowa: lead
• jkamholz: collaborator
• Workman, Craig D., PhD: collaborator

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: 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

Study Record Dates

• First Submitted: March 7, 2019
• First Posted: March 11, 2019
• Study Start: April 15, 2019
• Primary Completion: March 30, 2020
• Study Completion: March 30, 2020
• Last Updated: August 25, 2022
• Results First Posted: August 25, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)