Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 64 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
The purpose of the study is to test whether low-level electric stimulation, called High Definition transcranial Direct Current Stimulation (HDtDCS), on the part of the brain (i.e., left inferior frontal gyrus) thought to aid in memory will improve verbal retrieval in multiple sclerosis patients. The primary outcome measures are neuropsychological assessments of verbal retrieval, and the secondary measures are neuropsychological assessments of other cognitive abilities and electroencephalography (EEG) measures.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: * Participants must be between the ages of 18 and 64; * Participants must have a diagnosis of relapsing-remitting multiple sclerosis (RRMS). A physician's note verifying RRMS will be required if they are a patient outside the UT Southwestern network; * Participants must have a validated memory deficit: Validation will be done via neuropsychological testing at the initial/baseline visit using the Semantic Object Retrieval Test (SORT), COWAT (letter and category fluency), Boston Naming Test (BNT), and Auditory Verbal Learning Test (AVLT); neuropsychological test score on at least one verbal retrieval assessment (COWAT, BNT, AVLT) of a T-score less than 40 or a verbal retrieval test that was greater than 1.0 SD below the average T-score on SORT; * Participants must be fluent in speaking and reading English because testing materials are not available in other languages. Exclusion Criteria: * Relapse or acute MS exacerbation during the two months (60 days) preceding the baseline testing, with re-evaluation for inclusion possible after the 60 days of stability; * Less than 3 months (90 days) on a stable dose of benzodiazepines or modaphinil/armodafinil; * A history of a neurological disorder, other than RRMS, including dementia of any type, epilepsy or other seizure disorders, brain tumor, present drug abuse, stroke, blood vessel abnormalities in the brain, Parkinson's disease, or - - Huntington's disease; * Epilepsy or other seizure disorder; * Severe traumatic brain injury; * Unexplained episodes of loss of consciousness; * Suffering frequent headaches; * Unstable or uncontrolled psychiatric illness; * Brain tumor; * Serious or life-threatening diseases, including congestive heart failure, chronic obstructive pulmonary disease, or active malignancy; * Stroke; * Head implant or skull defects/damage that would affect HDtDCS administration or EEG recording; * Use of brain medical device; * Cardiac, neural, or medication implants that would affect HDtDCS administration or EEG recording; * Vascular clip; * Scalp skin condition like dermatitis, psoriasis, or eczema; * Current substance abuse, less than 1 year of discontinuation; Pregnancy; * Cognitive impairment due to an issue other than RRMS; * Telephone-administered Montreal Cognitive Assessment (TMoCA) Score \<19, unless accompanied by a legally authorized representative (LAR) to the consenting session; * Montreal Cognitive Assessment (MoCA) Score \<23, unless accompanied by an LAR to all sessions and both the participant and LAR provide consent; Not being able to give informed consent, unless accompanied by an LAR to all sessions and both the participant and LAR provide consent, and with consent ability assessed with a set of comprehension questions regarding the study and consenting to participate and with MoCA criteria above; * Medication Restrictions: Certain medications can temporarily change how your brain responds to electrical stimulation or affect EEG signals, and therefore are exclusionary: 1) Known medications that interact with tDCS efficacy: anti-convulsants, L-dopa, carbamazepine, sulpiride, pergolide, lorazepam, rivastigmine, dextromethorphan, D-cycloserine, flunarizine, ropinirole; 2) Medications that lower the seizure threshold; 3) Stimulant Medications (e.g., Adderall, Ritalin, often used for MS-related fatigue) cannot be taken during the course of the study; enrollment can be considered if the participant is willing to suspend use over the course of the study and suspension is coordinated with the prescribing physician); suspension must occur at least 3 days before any assessment session and must be maintained over the HDtDCS treatment phases of the study; * Steroid Medications (e.g., Prednisone, Decadron, IV Solu-Medrol, often used for MS relapses or inflammation treatment); If a participant has taken prescription steroid pills or received a steroid IV, they must wait at least 2 months (60 days) after your last dose before you can start tDCS treatments, although baseline testing will permissible within this 2-month waiting period.
Study sites (1)
TX
- Callier Clinical Researcher Center · Richardson, TX 75080Tyler Vintila, MS · Study contact · 972-833-3161 · Tyler.Vintila@UTDallas.eduJill Ritter, BA · Study contact · 972-833-3161 · jill.ritter@utdallas.eduJohn Hart, Jr, MD · Principal investigatorMichael A Motes, PhD · Sub-investigatorMore trials in Richardson