Trial Outcomes & Findings for Brain Stimulation and Visually-guided Navigation (NCT NCT04961645)

Last Updated: 2025-04-24

Results Overview

To assess performance during the visually-guided navigation computer-based task, rTMS is applied to to the control vertex site, which is not implicated in visually-guided navigation, as well as the occipital place area (OPA) site. While participants are shown simple visual stimuli of places (e.g., bedrooms, kitchens, and living rooms) they are asked to perform simple computer-based tasks (e.g., imagine they are walking through the room, and respond via button press whether they can leave through a door on the left, center, or right wall, as indicated by a continuous path on the floor). Performance is measured in task accuracy (the percentage of tasks performed correctly). A decrease in performance on the visually-guided navigation task only after rTMS is applied to OPA (but not vertex) indicates causal involvement of OPA in visually-guided navigation.

Recruitment status

TERMINATED

Study phase

Target enrollment

11 participants

Primary outcome timeframe

During rTMS of control site and during rTMS of OPA, on Day 1

Results posted on

2025-04-24

Participant Flow

Participants were recruited at Emory University in Atlanta, Georgia, USA. Participant enrollment began March 3, 2023 and the final study visit occurred May 17, 2023. The study was terminated in February 2025. The study was terminated prior to enrolling participants into the behavioral-based task study arm.

Participant milestones

Participant milestones
Measure	Repetitive Transcranial Magnetic Stimulation (rTMS) During Computer-based Task Participants receiving rTMS while they perform computer-based tests to examine the causal involvement of OPA in visually-guided navigation. The study visit lasts approximately 90 minutes. Repetitive Transcranial Magnetic Stimulation (rTMS): TMS is a safe and noninvasive method for affecting brain function relying on the properties of electromagnetic induction. Action potentials are triggered in neurons, along with a subsequent period of deactivation. Normal ongoing brain activity is disrupted providing a way for investigators to produce a transient and reversible period of brain disruption. Participants will be seated comfortably in a chair and asked to complete a simple computer-based task. During or just before each of these tasks, participants will receive rTMS. In rTMS, a small plastic coil is placed next to the participant's head. The coil will be placed over the relevant brain region identified during the participant's functional magnetic resonance (fMRI) scan. The coil will then generate a magnetic pulse, and stimulation will occur.	Repetitive Transcranial Magnetic Stimulation (rTMS) During Behavioral-based Task Participants receiving rTMS while they perform behavioral-based tests to examine the causal involvement of OPA in visually-guided navigation. The study visit lasts approximately 90 minutes. Repetitive Transcranial Magnetic Stimulation (rTMS): TMS is a safe and noninvasive method for affecting brain function relying on the properties of electromagnetic induction. Action potentials are triggered in neurons, along with a subsequent period of deactivation. Normal ongoing brain activity is disrupted providing a way for investigators to produce a transient and reversible period of brain disruption. Participants will be seated comfortably in a chair and asked to complete a simple behavioral task that will require them to walk around in a small room. During or just before each of these tasks, participants will receive rTMS. In rTMS, a small plastic coil is placed next to the participant's head. The coil will be placed over the relevant brain region identified during the participant's fMRI scan. The coil will then generate a magnetic pulse, and stimulation will occur.
Overall Study STARTED	11	0
Overall Study COMPLETED	11	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Brain Stimulation and Visually-guided Navigation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Repetitive Transcranial Magnetic Stimulation (rTMS) During Computer-based Task n=11 Participants Participants receiving rTMS while they perform computer-based tests to examine the causal involvement of OPA in visually-guided navigation.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: During rTMS of control site and during rTMS of OPA, on Day 1

Outcome measures

Outcome measures
Measure	Repetitive Transcranial Magnetic Stimulation (rTMS) During Computer-based Task n=11 Participants Participants receiving rTMS while they perform computer-based tests to examine the causal involvement of OPA in visually-guided navigation.
Accuracy During Visually-guided Navigation Computer-based Task rTMS Control Site	80.24 percent of task accuracy Standard Deviation 14.62
Accuracy During Visually-guided Navigation Computer-based Task rTMS Occipital Place Area (OPA)	82.44 percent of task accuracy Standard Deviation 14.42

PRIMARY outcome

Timeframe: During rTMS of control site and during rTMS of OPA, on Day 1

To assess performance during the visually-guided navigation computer-based task, rTMS is applied to to the control vertex site, which is not implicated in visually-guided navigation, as well as the occipital place area (OPA) site. While participants are shown simple visual stimuli of places (e.g., bedrooms, kitchens, and living rooms) they are asked to perform simple computer-based tasks (e.g., imagine they are walking through the room, and respond via button press whether they can leave through a door on the left, center, or right wall, as indicated by a continuous path on the floor). Performance is measured in the time (in milliseconds) that it takes to complete the task correctly. A decrease in performance on the visually-guided navigation task only after rTMS is applied to OPA (but not vertex) indicates causal involvement of OPA in visually-guided navigation.

Outcome measures

Outcome measures
Measure	Repetitive Transcranial Magnetic Stimulation (rTMS) During Computer-based Task n=11 Participants Participants receiving rTMS while they perform computer-based tests to examine the causal involvement of OPA in visually-guided navigation.
Reaction Time During Visually-guided Navigation Computer-based Task rTMS Control Site	644.23 milliseconds (ms) Standard Deviation 120.99
Reaction Time During Visually-guided Navigation Computer-based Task rTMS Occipital Place Area (OPA)	660.08 milliseconds (ms) Standard Deviation 109.22

PRIMARY outcome

Timeframe: During rTMS of control site and during rTMS of OPA, on Day 1

Population: The study was terminated prior to enrolling participants into the behavioral-based task study arm.

To assess performance during the visually-guided navigation behavior-based task, rTMS is applied to to the control vertex site, which is not implicated in visually-guided navigation, as well as the occipital place area (OPA) site. Participants are asked to complete simple behavioral-based tasks (e.g., actually walk around a small room and search for hidden objects). Performance is measured in task accuracy (the percentage of tasks performed correctly). A decrease in performance on the visually-guided navigation task only after rTMS is applied to OPA (but not vertex) indicates causal involvement of OPA in visually-guided navigation.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: During rTMS of control site and during rTMS of OPA, on Day 1

Population: The study was terminated prior to enrolling participants into the behavioral-based task study arm.

To assess performance during the visually-guided navigation behavioral-based task, rTMS is applied to to the control vertex site, which is not implicated in visually-guided navigation, as well as the occipital place area (OPA) site. Participants are asked to complete simple behavioral tasks (e.g., actually walk around a small room and search for hidden objects). Performance is measured as the time (in milliseconds) that it takes to complete the task correctly. A decrease in performance on the visually-guided navigation task only after rTMS is applied to OPA (but not vertex) indicates causal involvement of OPA in visually-guided navigation.

Outcome measures

Outcome data not reported

Adverse Events

Repetitive Transcranial Magnetic Stimulation (rTMS) During Computer-based Task

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Daniel Dilks, PhD

Emory University

Phone: 404-727-2980

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place