- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07561372
Adaptive Recruitment Curve Analysis Using Bayesian Modeling
Enhancing Speed and Accuracy of Motor Evoked Potential Recruitment Curve Analysis Using Hierarchical Bayesian Modeling
The purpose of this study is to better understand how electrical or magnetic stimulation affect the nervous system by optimizing the way researchers measure muscle responses. The relationship between stimulation intensity and muscle response is described by "neural recruitment curves," which are critical for monitoring the state of the nervous system during therapies like transcranial magnetic stimulation (TMS) and spinal cord stimulation (SCS).
This study tests a new, real-time computational approach based on our previously developed methods (Hierarchical Bayesian models) to estimate these recruitment curves more efficiently. The primary goal is to use this model to dynamically guide the experiment, automatically selecting the optimal stimulation intensities to test.
The investigators hypothesize that this optimized approach will accurately estimate the entire recruitment curve, or specific targets components of it like the motor threshold, using significantly fewer samples than standard methods. By reducing the number of measurements required, this approach aims to decrease experimental time and minimize participant burden, making future TMS and SCS therapies and experiments more feasible and efficient.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: James R McIntosh, PhD
- Phone Number: +19294352335
- Email: jrm2263@cumc.columbia.edu
Study Locations
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-
New York
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New York, New York, United States, 10032
- Columbia University Irving Medical Center
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Contact:
- James R McIntosh, PhD
- Phone Number: 9294352335
- Email: jrm2263@cumc.columbia.edu
-
Principal Investigator:
- James R McIntosh, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Healthy adults
Exclusion Criteria
- Presence of any neurological disorder
- History of seizures
- History of autonomic dysfunction
- Current use of seizure-threshold lowering medications
- Presence of metal implants
- History of prior neurosurgical interventions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Test of developed methods
Participants undergo distinct experiments within a single session to compare different neurostimulation sampling algorithms.
Each experiment involves recruitment curve sampling with different methods (e.g., Uniform, Expected Information Gain) to evaluate the accuracy and efficiency of motor threshold.
|
Standard uniform distribution sampling used as a baseline comparison.
Algorithm: Adaptive threshold hunting using the Parameter Estimation by Sequential Testing (PEST) algorithm.
The proposed algorithms will deliver stimulation by using this magnetic stimulation methodology.
The proposed algorithms will deliver stimulation by using this electrical stimulation methodology.
An active sampling algorithm for recruitment curve estimation.
An alternative active sampling algorithm for recruitment curve estimation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mean absolute threshold error
Time Frame: Through completion of the study visit, an average of 1 hour.
|
The threshold error of the methods under comparison, with the ground truth computed from recruitment curves fitted subsequent to sampling using aggregated data.
|
Through completion of the study visit, an average of 1 hour.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James R McIntosh, PhD, Columbia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AAAV6853
- 1R03NS141040-01A1 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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