Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIF
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
What it found
No result yet.
What was tested
Treatment tested
- High Definition transcranial Direct Current Stimulation
Placebo
- Sham High Definition transcranial Direct Current Stimulation
What it measured
Main measures
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Category Fluency
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Category Fluency
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Verbal Fluency
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Verbal Fluency
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Other measures (52)
Treatment group differences in change from baseline to 2-months post-treatment for Period 1 in Auditory Verbal Learning Test Delayed Memory
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Thinking and memoryTreatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 in Auditory Verbal Learning Test Delayed Memory
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Thinking and memoryTreatment group differences in change from baseline to 2-months post-treatment for Period 1 Picture Description Test Words Per Minute
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Period Picture Description Test Words Per Minute
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Period Picture Description Test Main Concepts Score
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Picture Description Test Main Concept Scores
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Period Picture Description Test Core Lexicon Score
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
12. Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Picture Description Test Core Lexicon Score
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Treatment group differences in change from baseline to 2-months post-treatment for Period1 Boston Naming Test Score
The outcome will be assessed as change over a period of 13 weeks: Change from Baseline to 2-months Post-Treatment Period 1 (week 13).
Treatment group differences in change from 2-months post-treatment for Period 1 to 2-months post-treatment for Period 2 Boston Naming Test Score
The outcome will be assessed as change over a period of 13 weeks: Change from 2-months Post-Treatment for Period 1 (week 13) to 2-months Post-Treatment for Period 2 (week 26).
Who could take part
Relapsing MS · 18 to 64
Show the full 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.
As registered. Criteria can change, so ask the trial team or your neurologist.
Contact details on the registryAbout this trial
In the sponsor's words
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.
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History
Started
Nov 2026
Main results due
Sept 2028
Finished
Sept 2029