Ignite Creation Date:
2024-05-06 @ 4:34 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05028738
Status:
UNKNOWN
Last Update Posted:
2021-11-09
First Post:
2021-08-07
Brief Title:
Patient-oriented Randomized Pragmatic Feasibility Trial With rTMS in Depression and Anxiety
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
Patient-oriented Randomized Pragmatic Feasibility Trial With rTMS in Depression and Anxiety
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
RECRUITING
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:
PORT
Brief Summary:
This trial compares intermittent theta-burst stimulation iTBS to low frequency repetitive transcranial magnetic stimulation LFR in regards to depression and anxiety outcomes in 100 patients with treatment resistant depression TRD
Detailed Description:
The overarching goal of this trial is to evaluate whether a definite adaptive pragmatic trial would be feasible and establish clear gono-go criteria as to whether proceeding to such definite trial is feasible Specific aims include 1 testing the feasibility of recruiting a sample of TRD patients with less strict inclusion and exclusion criteria 2 comparing different depression and anxiety scales both clinician-rated and self-rated and seek input from patients regarding their preferences 3 seek input from patients with regards to the use of digital phenotyping as a tool to investigate biomarkers as well as engaging in the design of a potential implementation of such biomarker in a future definite trial
Aim 1 To evaluate the feasibility of a future definite adaptive pragmatic RCT comparing left vs right DLPFC repetitive transcranial magnetic stimulation rTMS in TRD
Hypothesis 1a Enrollment will be 70 of the planned target over the 1-year recruitment period
Hypothesis 1b Retention rate of randomized participants will be 70 at the end of the intervention in both groups
Aim 2 To evaluate patients preferences regarding information about treatment options when there is no response to allocated treatment
Hypothesis 2 Patients will prefer to modify treatment when there is no response
Aim 3 To assess the feasibility of digital phenotyping as an tool to investigate biomarkers in TRD
Hypothesis 3a Survey uptake and participation in the study regarding the use of digital phenotyping will be 80 of randomized participants Hypothesis 3b Of those survey responders 75 will indicate they would consent to digital phenotyping in a future definite RCT
Aim 4 To develop a Bayesian statistical model that continuously updates personalized treatment effect estimates as the trial progresses and identify the circumstances under which use of the model in a full-scale trial could inform treatment choice as the trial progresses
Hypothesis 4 The modeling results will identify at least one subgroup for whom early stopping of the definitive trial in that subgroup may be warranted
Aim 1 To evaluate the feasibility of a future definite adaptive pragmatic RCT comparing left vs right DLPFC repetitive transcranial magnetic stimulation rTMS in TRD
Hypothesis 1a Enrollment will be 70 of the planned target over the 1-year recruitment period
Hypothesis 1b Retention rate of randomized participants will be 70 at the end of the intervention in both groups
Aim 2 To evaluate patients preferences regarding information about treatment options when there is no response to allocated treatment
Hypothesis 2 Patients will prefer to modify treatment when there is no response
Aim 3 To assess the feasibility of digital phenotyping as an tool to investigate biomarkers in TRD
Hypothesis 3a Survey uptake and participation in the study regarding the use of digital phenotyping will be 80 of randomized participants Hypothesis 3b Of those survey responders 75 will indicate they would consent to digital phenotyping in a future definite RCT
Aim 4 To develop a Bayesian statistical model that continuously updates personalized treatment effect estimates as the trial progresses and identify the circumstances under which use of the model in a full-scale trial could inform treatment choice as the trial progresses
Hypothesis 4 The modeling results will identify at least one subgroup for whom early stopping of the definitive trial in that subgroup may be warranted
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None