Non-invasive Transcranial Electrical Stimulation in MS

Multiple Sclerosis Clinical Trial

Official title:

Effects of Non-invasive Transcranial Electrical Stimulation on Cognition in Patients With Multiple Sclerosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04466228
• Other study ID #: FG-1908-34831
• Status: Completed
• Phase: N/A
• Start date: October 16, 2020
• Est. completion date: August 23, 2022

Study information

• Verified date: November 2023
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal is to investigate the effects of non-invasive transcranial electrical stimulation on cognition in MS.

Description:

The participants' baseline cognitive function will be assessed with a tablet-based, videogame-like software specifically designed as a medical device to test and train cognitive function for populations with cognitive disorders. After baseline test assessment, participants will receive stimulation while playing the training version of the software. After the stimulation, cognitive performance will be evaluated again with the testing version. Investigators will assess changes in cognitive performance associated with stimulation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: August 23, 2022
• Est. primary completion date: August 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• age 18-65,
• diagnosis of MS
• Expanded Disability Status Scale (EDSS)=6.5, no paresis of the upper limbs
• a minimum of 3 months since the last relapse
• Beck Depression Inventory<19
• normal hearing
• and no changes in MS or symptomatic medications in past 2 months

Exclusion Criteria:

• prior brain surgery
• clips in brain
• epilepsy or other neurological or non-affective psychiatric disorders
• pregnancy

Related Conditions & MeSH terms

• Cognitive Impairment
• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• non-invasive transcranial electrical stimulation
Non-invasive transcranial electrical stimulation across the prefrontal cortex.

Locations

Country	Name	City	State
United States	UCSF Sandler Neurosciences Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Processing Speed Change From Baseline Assessment	Symbol Digit Modalities Test (SDMT) score will be used to measure processing speed. SDMT measures the time to pair abstract symbols with specific numbers. The test requires visuoperceptual processing, working memory, and psychomotor speed. The score is the number of correctly coded items in 90 seconds. (max=110, min=0). Higher scores indicate improvement. Lower scores indicate worsening.	Baseline (pre-stim) and post-stimulation (up to 2 hours)
Primary	EVO Performance Change From Baseline Assessment	EVO tool is a digital cognitive assessment developed to assess cognitive function including attention and related cognitive control processes in clinical populations. It comes with the closed-loop adaptive algorithm which makes proportional changes in gameplay difficulty when the participant's performance deviates from an 80% rate of accuracy, which ensures that task difficulty is equated across participants and enhances engagement. Gameplay threshold (level 0 to level 20), response time and response time variability will be measured to evaluate attention control. Higher threshold level, lower response time and smaller response time variability indicate improvement.	Baseline (pre-stim) and post-stimulation, up to 2 hours