Clinical trial NCT05958381: Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation
Official title: Treatment of Cognitive Deficits in Multiple Sclerosis With High-Definition Transcranial Direct Current Stimulation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: transcranial direct current stimulation (tDCS)
multiple sclerosis
electroencephalography (EEG)
Lead sponsor: The University of Texas at Dallas
Sponsor class: OTHER
Collaborators: name: University of Texas Southwestern Medical Center
First posted: 2023-07-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to 1 of 2 treatment arms: (1) 1 milliamp transcranial direct current stimulation (tDCS) active treatment applied to presupplementary motor area for 20 minutes over 15 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 15 sessions and will be and re-evaluated at immediate- and 2-months follow-up testing sessions.
Primary purpose: TREATMENT

Brief summary: 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.

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

Primary outcomes:
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on Category Fluency
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on Category Fluency
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-month Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on COWAT
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on COWAT
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Secondary outcomes:
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part A)
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Trail Making Test (Part B)
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Delis Kaplan Color Word Interference Test
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on on the Digit Span Forward
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Span Backward
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on on the the Rey-Osterrieth Complex Figure Test
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Digit Symbol Substitution Test
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Grooved Pegboard Test
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval Test
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Boston Naming Test
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Auditory Verbal Learning Test
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part A)
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Trail Making Test (Part B)
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Delis Kaplan Color Word Interference Test
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Forward
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Span Backward
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Rey-Osterrieth Complex Figure Test
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Digit Symbol Substitution Test
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Grooved Pegboard Test
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval Test
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Boston Naming Test
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Auditory Verbal Learning Test
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Inhibition Task EEG spectral power
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Inhibition Task EEG spectral power
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Inhibition Task EEG Event-Related Potential (N2/P3)
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Inhibition Task EEG Event-Related Potential (N2/P3)
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval EEG spectral power
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval EEG spectral power
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 1-week Post-Treatment on the Semantic Object Retrieval EEG event-related potential
timeFrame: Outcome measures will be assessed as change over a period of 6 weeks: Change from baseline to 1-week Post-Treatment
measure: Treatment group differences in change from Baseline to 2-months Post-Treatment on the Semantic Object Retrieval EEG event-related potential
timeFrame: Outcome measures will be assessed as change over a period of 13 weeks: Change from baseline to 2-months Post-Treatment
Other outcomes:
Locations:
city: Richardson
country: United States
facility: The University of Texas at Dallas
state: Texas
Study officials:
affiliation: University of Texas at Dallas
name: John Hart, Jr, MD
role: PRINCIPAL_INVESTIGATOR
References: