## Protocol Section
### Identification Module
**NCT ID:** NCT06414213

**Acronym:** ELLMITS

**Brief Title:** Improving Locomotor Learning With Brain Stimulation

**Official Title:** Enhancing Locomotor Learning With Motor Imagery and Transcranial Direct Current Stimulation

#### Organization Study ID Info
**ID:** IRB-21-0198
#### Organization
**Class:** OTHER
**Full Name:** Appalachian State University
### Status Module
#### Completion Date
**Date:** 2022-12-22

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-09

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2022-12-22

**Type:** ACTUAL

#### Start Date
**Date:** 2022-09-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-09
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Appalachian State University

#### Responsible Party

**Investigator Affiliation:** Appalachian State University

**Investigator Full Name:** Jared Skinner

**Investigator Title:** Assistant Professor

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The primary goal of this research was to assess the practicality and initial effectiveness of a motor imagery (MI) intervention combined with elements of action observation (AO), alongside active or sham transcranial direct current stimulation (tDCS) over the prefrontal cortex (PFC), on locomotor learning in healthy adults. Feasibility was determined by examining recruitment rates, participant engagement, and safety measures. The efficacy of the intervention was gauged by analyzing the time taken to complete tasks and changes in cerebral blood flow immediately after the intervention and one week later. The study was guided by three main hypotheses: (1) the intervention techniques would be well-received and safe for the participants; (2) compared to a control group, MI training would lead to better learning outcomes and retention of learning; (3) in comparison to the control and sham tDCS groups, active tDCS would result in superior learning outcomes and retention of learning.

**Detailed Description:** The study implemented a double-blind, randomized, controlled trial design. Participants were tested three times over 7 days. After study enrollment, the participants were randomly assigned to one of three groups: MIActive (receiving active tDCS stimulation and participating in MI protocol), MISham (receiving sham tDCS stimulation and participating in MI protocol), and Control (receiving no stimulation and participating in an unrelated video-watching task) by a research member not associated with data collection. Allocation ratio was 1:1:1 and a block randomization approach was employed to maintain an equal distribution of participants across the three groups throughout the study. Study participants and assessors were blinded to assignment of active or sham tDCS. The independent variables were time (pre, post, and retention trials) and group (MIActive, MISham and Control), and the dependent variables were time to completion of a complex obstacle course and the amount of change in oxygenated hemoglobin (ΔO2Hb) during performance of that task.

### Conditions Module

**Conditions:**

- Motor Learning

**Keywords:**

- randomized

- double-blinded

- tDCS

- motor imagery

- functional near-infrared spectroscopy (fNIRS)

- controlled trial

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 38

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** The participants received active tDCS current and participated in the Motor Imagery intervention.

**Intervention Names:**

- Behavioral: Motor Imagery (MI)

- Device: Active tDCS

**Label:** MI/Active tDCS

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** The participants received sham tDCS current and participated in the Motor Imagery intervention.

**Intervention Names:**

- Behavioral: Motor Imagery (MI)

- Device: Sham tDCS

**Label:** MI/Sham tDCS

**Type:** SHAM_COMPARATOR

#### Arm Group 3

**Description:** The control group watched an unrelated (non stimulating) video for a duration equal to the MI groups' intervention tasks.

**Label:** Control

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- MI/Active tDCS

- MI/Sham tDCS

**Description:** Participants watched a standardized video sequence that consisted of an individual completing twenty walking trials (twenty video clips-each clip represents one trial). Participants were instructed to place their focus intently on the person performing the obstacle course and try to imagine themselves doing the skill. Periodically, a reminder would appear to help focus and redirect participant's attention to different aspects of the video or different versions of imagery (visual or kinesthetic). Participants will watch the video first at normal play speed and then in slow motion after a short break (30 secs to 1 min). Total training time will be approximately 20 mins which is consistent with the duration of the locomotor intervention and duration of stimulation.

**Name:** Motor Imagery (MI)

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- MI/Active tDCS

**Description:** The participants received a 20-minute "active" session of tDCS at a 2-milliamp current.

**Name:** Active tDCS

**Type:** DEVICE

#### Intervention 3

**Arm Group Labels:**

- MI/Sham tDCS

**Description:** The participants received a 20-minute session of "sham" tDCS.

**Name:** Sham tDCS

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Functional near infrared spectroscopy (fNIRS) monitor (OctaMon by Artinis Medical Systems), changes in oxygenated hemoglobin concentration (O2Hb) relative to a baseline task

**Measure:** Prefrontal cortical activity

**Time Frame:** Baseline to 1 week follow up

**Description:** number of sessions attended

**Measure:** Adherence to interventions

**Time Frame:** Baseline to 1 week follow up

**Description:** number of participants completing intervention and follow-up assessment

**Measure:** Retention of participants

**Time Frame:** Baseline to 1 week follow up

**Description:** Number of unexpected and/or serious adverse events

**Measure:** Adverse events in each study arm

**Time Frame:** Baseline to 1 week follow up

**Description:** Recorded time to complete the obstacle course

**Measure:** Time to completion

**Time Frame:** Baseline to 1 week follow up

**Description:** Gait velocity, measured in meters/sec, was recorded using a zeno walkway gait analysis system. ProtoKinetics Movement Analysis Software was used to collect and analyze the data.

**Measure:** Gait velocity

**Time Frame:** Baseline to 1 week follow up

#### Secondary Outcomes

**Description:** The Montreal Cognitive Assessment (MoCA) is a widely used screening tool designed to assess various cognitive domains, including memory, attention, language, visuospatial skills, executive function, and orientation. During a MoCA test, individuals are presented with a series of tasks and questions that challenge different aspects of cognitive function. These tasks may include remembering a list of words, drawing a certain shape, following complex instructions, and identifying similarities between words or objects.

**Measure:** Cognitive Assessment

**Time Frame:** Baseline to 1 week follow up

**Description:** The ability to imagine movements was assessed with the Kinesthetic and Visual Imagery Questionnaire (KVIQ). This test evaluates the subject's ability to see (visual imagery) and feel (kinesthetic imagery) movements. The KVIQ consists of 10 items, (5 movements for each scale), each item being a separate movement followed by rating the ease or difficulty of generating those self-images on a 5-point Likert scale (where 1 = no image or sensation and 5 = Image as clear as seeing or as intense as executing the action). Higher scores reflected higher imagery abilities.

**Measure:** Kinesthetic and Visual Imagery Questionnaire (KVIQ)

**Time Frame:** Baseline to 1 week follow up

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Male and female adults age 18 and older
* Freely ambulatory (no assistive walking aids)

Exclusion Criteria:

* Failure to meet specific inclusion criteria
* History or presence of any neurological disease
* Low visual ability, operationally defined as visual acuity less than 20/70 on the standard eye chart
* Extreme difficulty performing walking tasks due to low visual ability
* Clinical judgment of the investigative team
* Additionally, subjects who are determined to be at increased risk for adverse events during the tDCS procedure, as determined by the tDCS screening questionnaire

**Healthy Volunteers:** True

**Maximum Age:** 99 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Boone

**Country:** United States

**Facility:** Appalachian State University

**State:** North Carolina

**Zip:** 28607

#### Overall Officials

**Official 1:**

**Affiliation:** Appalachian State University

**Name:** Jared W Skinner, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**Description:** There is not a plan to make Individual Participant Data (IPD) available.

**IPD Sharing:** NO

### References Module

#### References

**Citation:** Clark DJ, Chatterjee SA, Skinner JW, Lysne PE, Sumonthee C, Wu SS, Cohen RA, Rose DK, Woods AJ. Combining Frontal Transcranial Direct Current Stimulation With Walking Rehabilitation to Enhance Mobility and Executive Function: A Pilot Clinical Trial. Neuromodulation. 2021 Jul;24(5):950-959. doi: 10.1111/ner.13250. Epub 2020 Aug 18.

**PMID:** 32808403

## Derived Section

### Misc Info Module

#### Submission Tracking

- Estimated Results First Submit Date: 2024-05-22

##### Submission Infos

- MCP Release N: Unknown

- Release Date: 2024-05-22

- Reset Date: Unknown

- Unrelease Date: Unknown

- Unrelease Date Unknown: Unknown

- Version Holder: 2024-05-31
