Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial Direct Current Stimulation, Sham transcranial direct current stimulation.
- Who it may be relevant to
- Registry conditions: Multiple Sclerosis, Relapsing-Remitting. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The purpose of the study is to test whether low level electric stimulation, called transcranial Direct Current Stimulation (tDCS), on the part of the brain (i.e., presupplementary motor area) 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. Additionally, the study will examine the degree to which baseline assessments of cognition and concussion history predict responses to treatment over time, both on assessments administered within the intervention period and at follow-up.
Detailed description
Using two treatment arms, the study will examine improvement of verbal retrieval and other cognitive deficits associated with multiple sclerosis by comparing (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 10 sessions to (2) sham tDCS following the same schedule. Additionally, after completing the initial active or sham treatment and immediate and 2-month follow-up testing sessions, selected participants will be invited back for newly assigned treatment conditions, 20 minutes over 10 sessions and will be re-evaluated at immediate and 2-month follow-up testing sessions.
Patients with multiple sclerosis and observed cognitive deficits will be randomly assigned to one of the two treatment arms (and re-assigned for the second round of intervention, as described above). Primary outcome verbal retrieval measures, secondary neuropsychological and electroencephalography (EEG) measures, and prescreening assessments for study concussion history and contraindications for treatment will be collected prior to being assigned to a treatment arm (i.e., baseline).
Primary outcome verbal retrieval measures and secondary neuropsychological and electroencephalography (EEG) measures will be at baseline and two times following treatment competition (i.e., immediate and 2-months). For participants selected for the second round of intervention, primary outcome verbal memory measures and secondary neuropsychological and electroencephalography (EEG) measures will be collected again two times immediately following completion of the last treatment and 2-months afterward.
Interventions
- Device Transcranial Direct Current Stimulation
Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seco - Device Sham transcranial direct current stimulation
Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds
Primary outcome measures
- Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 2-months Post-Treatment on Category Fluency [Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment]
- Treatment group differences in change from Baseline to 1-week Post-Treatment on COWAT [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 2-months Post-Treatment on COWAT [Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Secondary outcome measures (12)
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part A) [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part B) [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Delis Kaplan Color Word Interference Test [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 1-week Post-Treatment on on the Digit Span Forward [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Span Backward [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 1-week Post-Treatment on on the the Rey-Osterrieth Complex Figure Test [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Symbol Substitution Test [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Grooved Pegboard Test [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval Test [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Boston Naming Test [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 1-week Post-Treatment on the Auditory Verbal Learning Test [Time frame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment]
- Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part A) [Time frame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment]
Eligibility criteria
Inclusion criteria
º Diagnosed with relapsing-remitting multiple sclerosis (RRMS)
º Memory retrieval deficit based on neuropsychological testing done in our lab
º Must be fluent in speaking and reading English.
Exclusion criteria
º Relapse or acute MS exacerbation or a course of steroids in the two months preceding the testing
º Participants using benzodiazepines must have been on a stable dose for at least two months
º Potentially confounding psychological or neurological disorder, including:
- dementia of any type
- epilepsy or other seizure disorders
- severe traumatic brain injury
- brain tumor
- present drug abuse
- stroke
- blood vessel abnormalities in the brain
- Parkinson's disease
- Huntington's disease
º inability to give informed consent
º cranial implants
º skull defects that affect tDCS administration
º use of medications that interact with or potentially interact with tDCS effects, including:
- anti-convulsants
- L-dopa
- carbamazepine
- sulpiride
- pergolide
- lorazepam
- rivastigmine
- dextromethorphan
- D-cycloserine
- flunarizine
- ropinirole
- stimulants (dextroamphetamine/amphetamine/modafinil/armodafinil) must be stopped during enrollment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The University of Texas at Dallas — Richardson
Identifiers
NCT: NCT05958381 · 23-521 · HT94252310618 · E04675.1a