Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06639594
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-10
Brief Title:
Feasibility of Accelerated Personalized rTMS as an Adjuvant for Impulse Control Disorders a Pilot Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of Accelerated Personalized rTMS as an Adjuvant for Impulse Control Disorders a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 ie 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 ie 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None