Transcranial Direct Current Stimulation (tDCS) for Multiple Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
NYU Langone Health, New York, NY
Multiple Sclerosis+3 More
Transcranial Direct Current Stimulation (tDCS) - Other
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a brain stimulation device can help people with multiple sclerosis and cannabis use disorder.

See full description

Eligible Conditions

  • Multiple Sclerosis
  • Cannabis Use Disorders

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Transcranial Direct Current Stimulation (tDCS) will improve 1 primary outcome and 6 secondary outcomes in patients with Multiple Sclerosis. Measurement will happen over the course of Baseline.

Baseline
Age of Onset of Cannabis Use
Week 6, Month 3
Change in Cannabis Withdrawal Scale (CWS) Score
Change in Frequency of Cannabis Use
Change in Kessler Psychological Distress Scale (K10) Score
Change in Marijuana Craving Questionnaire (MCQ-17) Score
Change in Number of Daily Sessions of Cannabis Use
Change in Positive and Negative Affect Schedule (PANAS-SF) Score

Trial Safety

Trial Design

2 Treatment Groups

Active tDCS + Mindfulness
1 of 2
Sham tDCS + Mindfulness
1 of 2
Experimental Treatment
Non-Treatment Group

This trial requires 46 total participants across 2 different treatment groups

This trial involves 2 different treatments. Transcranial Direct Current Stimulation (tDCS) is the primary treatment being studied. Participants will all receive the same treatment. Some patients will receive a placebo treatment. The treatments being tested are not being studied for commercial purposes.

Active tDCS + Mindfulness
Sham tDCS + Mindfulness

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: week 6, month 3
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly week 6, month 3 for reporting.

Closest Location

NYU Langone Health - New York, NY

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Multiple Sclerosis or one of the other 3 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The DSM-5 defines Cannabis Use Disorder as a condition in which people meet the criteria for Cannabis Use Intoxication and for Cannabis Use Disorder show original
The person has a K10 score of between 10 and 35, which means they are experiencing mild to high levels of distress. show original
This person has a PDDS score of 0-7, which means that they have a mild to moderate neurological disability show original
Being able to understand the information given in the consent form, and providing consent to take part in the study. show original
is advised If you are looking to reduce or stop your cannabis use, it is advised that you seek treatment. show original
All medications that were stable for at least one month prior to enrollment and throughout the trial. show original
We will provide you with stable and continuous access to internet service, as well as email access through a WiFi hotspot if needed. show original
Ages 21-65 (inclusive)
Ability to use mobile devices
The person has MS, and it is a relapsing remitting subtype. show original

Patient Q&A Section

What causes multiple sclerosis?

"There is no single cause for MS. Many factors are believed to be involved in causing MS and its different stages. It is unknown exactly how the brain damage leads to MS. MS can run in families. A genetic defect has been found in some individuals with MS.\n" - Anonymous Online Contributor

Unverified Answer

Can multiple sclerosis be cured?

"Results from a recent clinical trial suggests that early intervention to promote patient engagement or to facilitate coping strategies may be effective in reducing disability and increasing well being." - Anonymous Online Contributor

Unverified Answer

What are the signs of multiple sclerosis?

"Most patients with MS have signs of fatigue or weakness. Numbness, muscle pain, or weakness in an extremity is more related to an early stage of the disease, whereas visual symptoms, cognition, and mental disturbances are related to a later stage of the illness, or to progressive multifocal leukoencephalopathy. Optic nerves involvement is a common finding, since optic neuritis may occur early in the course of the disease with transient or prolonged courses of neurological deterioration before a more stable state is reached and clinical improvement occurs." - Anonymous Online Contributor

Unverified Answer

What is multiple sclerosis?

"MS is an autoimmune disease that affects many people of all countries. The diagnosis is based on the existence of one or more lesions on brain imaging. Typically a course of high-dose immunomodulating therapy, such as interferon beta or fingolimod, is used to halt progression and improve prognosis. Also for children, relapse is a common problem and treatment is similar to MS in adults. A number of monoclonal antibody therapies are approved for children. There are no vaccines available for people with MS. Also, there is an unknown cause of MS. summary: This article describes the causes of multiple sclerosis, the symptoms and treatments." - Anonymous Online Contributor

Unverified Answer

How many people get multiple sclerosis a year in the United States?

"around 43,300 adults in the United States are diagnosed with MS that year.MS is a neurological disorder in which the brain's white and gray matter, and the nerves that connect them, are damaged, leading to symptoms such as weakness or numbness in the limbs, and problems with coordination and movement. MS is a clinically and pathologically heterogeneous disorder with several types of disease manifestation. MS is not the result of infection. Most cases are unknown and called "MSsuspic[tion] syndrome". Many of these patients are considered to have "diagnostic uncertainty". In many cases MS is not diagnosed because the initial presentation of the disease is usually outside of the criteria for MS." - Anonymous Online Contributor

Unverified Answer

What are common treatments for multiple sclerosis?

"Multiple sclerosis (MS) is a progressive neurological disease characterized by the degeneration of myelination in the central nervous system. As of 2015, no cure is known. The progressive loss of functional capacity leads to an increasingly disabling disease. Treatment of MS generally consists of pharmacologic or surgical measures intended to reduce its manifestations. A growing proportion of MS patients, approximately 10% at the time of diagnosis, develop clinically definite progressive disease in some time. These patients may respond to treatments whose primary purpose is to halt progressive disability." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for multiple sclerosis?

"The current criteria for considering a trial have been developed from the expertise of the investigators and from the expertise of the patients. However, these trials represent only a fraction of those being conducted. Because the current criteria exclude more than three quarters of MS patients, investigators and patients should be encouraged to test in more tailored approaches criteria for considering clinical trials." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in transcranial direct current stimulation (tdcs) for therapeutic use?

"tDCS may lead to beneficial results in MS, however, the mechanism by which tDCS exerts its therapeutic effects is not entirely understood. In addition, there is a continuing need to improve tDCS techniques for larger-scale clinical studies in MS. ClinicalTrials.gov (www.clinicaltrials.gov) Identifiers NCT00163548, NCT00526951, NCT00457724, and NCT00531510." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of transcranial direct current stimulation (tdcs)?

"Findings from a recent study, side effects from tDCS at 600 mA and with 400 pulses consisted of a transient sense of tingling over the head. These side effects were mostly mild and transient and were not clinically significant. In addition, the results did not suggest a relationship between side effects and stimulator output." - Anonymous Online Contributor

Unverified Answer

Is transcranial direct current stimulation (tdcs) typically used in combination with any other treatments?

"TDCS has shown to produce promising results for treating spasticity and pain in MS. However, further study is needed to understand its effectiveness and safety in combination with other treatments in MS\n" - Anonymous Online Contributor

Unverified Answer

What is the latest research for multiple sclerosis?

"There is now more information being published than at any other time. The research is going deeper into why the disease takes the way it does, and is beginning to offer options for the future treatment and the recovery.\n" - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving transcranial direct current stimulation (tdcs)?

"The safety of this technology requires further evaluation in terms of possible long-term treatment side effects on vision, brain, cognitive functioning, fatigue, pain, mood and physical abilities, especially balance. There is ongoing participation in a multicenter trial of 20 patients with multiple sclerosis (MS) enrolled as outpatients, and two clinical trials aimed toward studying the impact of multiple sessions of transcranial direct current stimulation on fatigue, fatigue remission and brain atrophy." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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