How Does Cerebellar tDCS Alter Intracortical Inhibition Over Time?

NCT ID: NCT06384495

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-15

Study Completion Date

2025-08-10

Brief Summary

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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.

Detailed Description

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Conditions

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Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Real anodal tDCS group (REAL-A)

Participants randomized to REAL-A

Group Type EXPERIMENTAL

REAL-A

Intervention Type PROCEDURE

one session of 2mA for 20 minutes to the right ventro-lateral cerebellum

Real cathodal tDCS group (REAL-C)

Participants randomized to REAL-C

Group Type EXPERIMENTAL

REAL-C

Intervention Type PROCEDURE

one session of 2mA for 20 minutes to the right ventro-lateral cerebellum

Sham group (SHAM)

Participants randomized to SHAM group

Group Type SHAM_COMPARATOR

SHAM

Intervention Type PROCEDURE

one session of sham tDCS for 20 minutes to the right ventro-lateral cerebellum.

Interventions

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REAL-A

one session of 2mA for 20 minutes to the right ventro-lateral cerebellum

Intervention Type PROCEDURE

REAL-C

one session of 2mA for 20 minutes to the right ventro-lateral cerebellum

Intervention Type PROCEDURE

SHAM

one session of sham tDCS for 20 minutes to the right ventro-lateral cerebellum.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Minnesota

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sharyl Samargia-Grivette

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

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University of Minnesota

Minneapolis, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00021475

Identifier Type: -

Identifier Source: org_study_id

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