Transcranial Direct Current Stimulation to Lower Neuropathic Pain in People With Multiple Sclerosis

NCT03219073 | Terminated Results FDA Device

• 1 other identifier: 17-0690
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

Transcranial Direct Current Stimulation (tDCS) is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to apply currents to the brain and modulate the level of cortical excitability. tDCS applied over the dorsolateral prefrontal and motor cortex has been reported to be able to decrease pain sensation and to increase pain threshold in healthy subjects and is effective in reducing central chronic pain in patients with multiple sclerosis (PwMS.) In spite of the encouraging results of tDCS in PwMS, detailed mechanisms accounting for its analgesic effect have not yet been elucidated. This will be the first study to determine the effects of tDCS on whole and regional brain activity in PwMS with neuropathic pain to identify potential mechanisms of the analgesic effects of tDCS. These findings will provide targets for future studies investigating different stimulation areas, possible short- and long-term side effects, and specific target areas for other precise stimulation techniques such as transcranial magnetic stimulation.

Conditions

Multiple Sclerosis; Neuropathic Pain

Keywords

multiple sclerosis; neuropathic pain; [18F] FDG-PET CT; tDCS; transcranial direct current stimulation

Outcome Measures

Primary Outcomes (1)

• Cerebral Glucose Uptake in Patients With Multiple Sclerosis With Neuropathic Pain

  Whole and regional brain glucose uptake via positron emission tomography with a glucose analogue tracer will be measured to determine the mechanistic effect of transcranial direct current stimulation on brain activity in subjects. Glucose uptake will be determined in patients with multiple sclerosis who received brain stimulation and patients with multiple sclerosis who received SHAM. The outcome variable is the mean Standardized Uptake Value.

  1 week

Secondary Outcomes (2)

• Change in Neuropathic Pain as Recorded on a Visual Analog Scale (VAS).

  1 week

• Change in Neuropathic Symptom Inventory

  1 week

Study Arms (2)

SHAM tDCS

SHAM COMPARATOR

SHAM tDCS using tDCS device will be used for sham stimulation where the electrodes will be placed in the same positions as for anodal M1 stimulation, but the stimulator will be turned off after 90 seconds. Therefore, the patients feel the initial itching sensation but receive no current for the rest of the stimulation period.

Device: SHAM tDCS using tDCS device

Active tDCS with a tDCS device

ACTIVE COMPARATOR

Active tDCS using tDCS device (Neuroelectrics Inc., Simi Valley, CA, USA) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The anodal electrode will be placed over the M1 contralateral to the worst somatic pain area (C3, EEG 10/20 system) and the cathode over the supraorbital area contralateral to the anodal electrode. A constant current of 2 mA intensity will be applied for 20 minutes once a day for 5 consecutive days.

Device: Active tDCS using tDCS device

Interventions

Active tDCS using tDCS device DEVICE

Active tDCS using tDCS device is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to apply currents to the brain and modulate the level of cortical excitability. tDCS applied over the dorsolateral prefrontal and motor cortex has been reported to be able to decrease pain sensation and to increase pain threshold in healthy subjects and is effective in reducing central chronic pain in PwMS.

Active tDCS with a tDCS device

SHAM tDCS using tDCS device DEVICE

SHAM tDCS emulates active tDCS in all but the actual stimulation. Electrodes of the tDCS device are placed in the same place as with active tDCS however no current is activated.

SHAM tDCS

Eligibility Criteria

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

You may qualify if:

• Patients with Multiple Sclerosis (PwMS)
• Age range 18-65
• Expanded disability status scale comprised between 1.5 and 6.5 with relapsing remitting MS (RRMS) in remitting phase
• Presenting with chronic, drug-resistant, neuropathic pain
• Patients must score at or above a 0 on the Neuropathic Pain Questionnaire (NPQ).
• Patients must score at least a 40 mm on the visual analog scale (VAS) for pain perception at baseline
• All analgesic medications discontinued at least 24 hours before entering the study

You may not qualify if:

• Any change in:
• disease-modifying medications, or
• a relapse of disease symptoms within the last 60 days
• History of seizures
• History of traumatic brain injury
• History of claustrophobia
• Presence of:
• pacemakers,
• aneurysm clips,
• artificial heart valves,
• metallic prostheses, or
• pregnancy.
• Recent hospitalization (within the last 3 months)
• Enforced bed rest/sedentary state
• Resting plasma glucose greater than 200 mg/dl

Sponsors & Collaborators

• Thorsten Rudroff: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis; Neuralgia

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Thorsten Rudroff
• Organization: University of Iowa

thorsten-rudroff@uiowa.edu

17205323701

Study Officials

• Thorsten Rudroff, Ph.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Patients and assessing investigator will be blinded to group allocation while the treating investigator, who has to set the tDCS or sham-stimulation protocol on the stimulator, will be the only person aware of the stimulation condition. To minimize communication between blinded and non-blinded participants, the treating investigator will be instructed not to talk to patients and the assessing investigator about the study protocol.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: Two age and sex matched groups, each n =8, will be randomized to receive either tDCS or SHAM stimulation.

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: July 17, 2017
• Study Start: February 1, 2018
• Primary Completion: June 16, 2018
• Study Completion: July 1, 2018
• Last Updated: November 29, 2022
• Results First Posted: November 29, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)