Clinical trial NCT06384495: How Does Cerebellar tDCS Alter Intracortical Inhibition Over Time?
Official title: How Does Cerebellar tDCS Alter Intracortical Inhibition Over Time?
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Combining cortical tDCS with behavioral interventions has been shown to have beneficial outcomes in individuals post-stroke. However, cerebellar tDCS is a fairly new approach for individuals with unilateral cortical stroke and there has not been reports of duration of effect of tDCS applied to the cerebellum in this population.

Information gained from this study will serve to fill knowledge gaps on the duration of effect of cerebellar tDCS and the effects of polarity.

The purpose of this study is to determine the duration of effect of ventro-lateral cerebellar transcranial direct current stimulation (tDCS) in healthy adults through cortical excitability (CE), cognitive, language and motor assessment measures. Primary aim: Compare baseline CE from left motor cortex of first dorsal interosseous (FDI) and orbicularis oris (OO) areas to CE post cerebellar tDCS at 15 minutes, 45 minutes and 75 minutes. Single-pulse and paired-pulse transcranial magnetic stimulation (TMS) will be used to measure and compare stimulus response curve (S/R curve), cortical silent period (CSP) and short-interval intracortical inhibition (SICI) in the hand area and facial area of the left primary motor cortex at each time point.

Secondary aim: Compare baseline performance on cognition, motor learning and language tasks to performance at 15, 45 and 75 minutes after receiving tDCS. Digit Symbol Substitution Test (DSST), Serial Reaction Time Test (SRTT) and Lexical Decision tasks will be presented via a computer interface.


Eligibility criteria: Inclusion Criteria:

* Eligible participants must be over the age of 18 years of age
* must be fluent in English
* have adequate vision to see a computer screen from 12-18 inches, fine motor skills to press a key on a computer keyboard and hearing to hear directions and questions provided by the researcher
* Individuals must also be able to read words and phrases

Exclusion Criteria:

* Pregnancy
* history of seizures
* neurologic injury including concussion/head injury or stroke or other neurologic conditions
* History of documented learning disabilities and/or ADHD
* Metal implants in the body (excluding dental fillings), psoriasis or eczema affecting the scalp.

Primary outcomes:
measure: stimulus/response curve (S/R Curve)
timeFrame: baseline, 15,45 and 75 minutes post-tDCS
measure: Cortical Silent Period (CSP)
timeFrame: baseline, 15,45 and 75 minutes post-tDCS
measure: Short-interval Intracortical Inhibition (SICI).
timeFrame: baseline, 15,45 and 75 minutes post-tDCS
Secondary outcomes:
measure: Digit Symbol Substitution Test (DSST)
timeFrame: baseline, 15, 45 and 75 minutes post stimulation
measure: Serial Reaction Time Test (SRTT)
timeFrame: baseline, 15, 45 and 75 minutes post stimulation
measure: Lexical Decision Task
timeFrame: baseline, 15, 45 and 75 minutes post stimulation
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Sharyl Samargia-Grivette
role: PRINCIPAL_INVESTIGATOR
References: