Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-29 @ 7:38 PM
Study NCT ID:
NCT06639594
Status:
RECRUITING
Last Update Posted:
2025-10-02
First Post:
2024-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Feasibility of Accelerated, Personalized rTMS as an Adjuvant for Impulse Control Disorders: a Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPID
Brief Summary:
To learn if accelerated rTMS (repetitive transcranial magnetic stimulation) can be used as a possible therapy for excessive eating.
Detailed Description:
Primary Objectives:
To evaluate the feasibility of using accelerated rTMS as a potential treatment adjuvant, we will assess the following feasibility primary outcomes:
-Recruitment: We will define recruitment as the probability of an eligible participant consenting to participate in the study.
We will deem recruitment for this trial feasible if at least 70% of eligible participant consent to participate in the trial. (i.e., considering a pool of 30 eligible participant, we consent at least 21 participants).
* Tolerability: For each protocol, we will follow an up-titration procedure (from 80% up to 110% of the motor threshold) and define the optimally tolerable dose (OTD) as the dose that at least 70% of participants can tolerate. Tolerability will be computed separately for each rTMS protocol.
* Safety: To consider the treatment safe, there must be no serious adverse events attributable to rTMS.
Secondary Objectives
We will measure:
1. To measure the time required to the staff to conduct each ERP assessment.
2. To measure the time between the end of the last rTMS session and the start of the second ERP assessment.
We will analyze each measure to obtain an accurate estimate of the duration of each step in the procedures. Our ultimate goal is to develop image-guided, personalized rTMS interventions. Carefully assessing the time required for each step in the protocol will allow us to identify opportunities to further optimize our procedures and reduce the duration of future visits.
3. We will conduct exploratory analyses on the amplitude of the late positive potential (LPP) component of the ERPs. Our exploratory analyses will allow us to estimate the LPP responses collected from the "cued food delivery task" before and after the rTMS intervention and assess the level of noise in the data by computing the standardized measurement error (SME).
To evaluate the feasibility of using accelerated rTMS as a potential treatment adjuvant, we will assess the following feasibility primary outcomes:
-Recruitment: We will define recruitment as the probability of an eligible participant consenting to participate in the study.
We will deem recruitment for this trial feasible if at least 70% of eligible participant consent to participate in the trial. (i.e., considering a pool of 30 eligible participant, we consent at least 21 participants).
* Tolerability: For each protocol, we will follow an up-titration procedure (from 80% up to 110% of the motor threshold) and define the optimally tolerable dose (OTD) as the dose that at least 70% of participants can tolerate. Tolerability will be computed separately for each rTMS protocol.
* Safety: To consider the treatment safe, there must be no serious adverse events attributable to rTMS.
Secondary Objectives
We will measure:
1. To measure the time required to the staff to conduct each ERP assessment.
2. To measure the time between the end of the last rTMS session and the start of the second ERP assessment.
We will analyze each measure to obtain an accurate estimate of the duration of each step in the procedures. Our ultimate goal is to develop image-guided, personalized rTMS interventions. Carefully assessing the time required for each step in the protocol will allow us to identify opportunities to further optimize our procedures and reduce the duration of future visits.
3. We will conduct exploratory analyses on the amplitude of the late positive potential (LPP) component of the ERPs. Our exploratory analyses will allow us to estimate the LPP responses collected from the "cued food delivery task" before and after the rTMS intervention and assess the level of noise in the data by computing the standardized measurement error (SME).
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2024-08561 | OTHER | NCI CTRP Clinical Registry | View |