Ignite Creation Date:
2024-05-06 @ 4:32 PM
Last Modification Date:
2024-10-26 @ 2:12 PM
Study NCT ID:
NCT05017857
Status:
WITHDRAWN
Last Update Posted:
2022-02-28
First Post:
2021-07-27
Brief Title:
Feasibility of Problem Solving Training Paired With Transcranial Magnetic Stimulation
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
Exploring the Feasibility of Problem Solving Training Paired With Transcranial Magnetic Stimulation to Improve Problem-solving Skills After Stroke
Status:
WITHDRAWN
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study PI is leaving the institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objectives of this pilot project are to determine whether pairing rTMS with an evidence-based PST intervention is acceptable to and feasible for individuals with executive function deficits after stroke and whether rTMS enhances executive functioning and uptake of the PST intervention to improve generalization of the PST strategy and support long-term goal attainment To achieve the objectives the investigators propose two specific aims
AIM 1 Establish the acceptability and feasibility of delivering up to 6 sessions of PST rTMS to individuals with executive function deficits 6 months post stroke Hypothesis 1a80 participants will complete 6 PST sessions Hypothesis 1b 1b Participants who receive rTMS directly prior to the PST intervention will report higher satisfaction with the overall intervention compared to those who receive rTMS simultaneously with PST
AIM 2 Assess the initial efficacy of PSTrTMS for improving patient outcomes in individuals with stroke Hypothesis 2a Patients will demonstrate a significant increase in executive functioning ie attention immediate memory and cognitive flexibility and reasoning as measured by the Digit Span Test and Wisconsin Card Sorting Test Hypothesis 2b Patients will achieve 80 of self-set goals Hypothesis 2c Patients will demonstrate a significant increase in task-oriented coping skills as measured by the Brief Cope at 1-month post intervention
AIM 1 Establish the acceptability and feasibility of delivering up to 6 sessions of PST rTMS to individuals with executive function deficits 6 months post stroke Hypothesis 1a80 participants will complete 6 PST sessions Hypothesis 1b 1b Participants who receive rTMS directly prior to the PST intervention will report higher satisfaction with the overall intervention compared to those who receive rTMS simultaneously with PST
AIM 2 Assess the initial efficacy of PSTrTMS for improving patient outcomes in individuals with stroke Hypothesis 2a Patients will demonstrate a significant increase in executive functioning ie attention immediate memory and cognitive flexibility and reasoning as measured by the Digit Span Test and Wisconsin Card Sorting Test Hypothesis 2b Patients will achieve 80 of self-set goals Hypothesis 2c Patients will demonstrate a significant increase in task-oriented coping skills as measured by the Brief Cope at 1-month post intervention
Detailed Description:
The investigators plan to conduct a small 2-group feasibility trial with assessment at initial visit final visit visit 6 and 1 month post intervention
Research Design and Methods The investigators will conduct a feasibility pilot trial of PSTrTMS in 4 adults with chronic stroke --to assess if the intervention is acceptable to Client Satisfaction Questionnaire-8 and feasible for sessions completed percentage of rTMS intensity reductions individuals with executive function deficits after stroke and whether rTMS enhances 1 attention and immediate memory digit span 2 cognitive flexibility and reasoning Wisconsin Card Sorting Task and 3 uptake uptake questionnaire of the PST intervention to improve 4 self-efficacy General Self-Efficacy Scale 5 generalization Goal Attainment Scaling-trained vs untrained goals Brief Cope of the PST strategy and support long-term goal attainment Goal Attainment Scaling at 1 months Outcomes will be assessed at baseline completion of intervention and 1-months post
Sample Size 4 participants will be enrolled The pilot data from this study will provide the parameter estimates necessary to perform sample size determination for a future large randomized control trial
Data Collection The PI will perform set-up and application of the TMS coil and will administer the assessments at baseline visit 1- in person completion of intervention visit 6-in person and 1-months post intervention completion via RedCap link that is emailed to the participant or via phone call participants preference All intervention sessions will be audio-recorded to ensure fidelity Data will be stored in RedCap database
Primary Outcome Measures
Demographics Caregiver Appraisal of functional dependence modified Safety questionnaire for TMS Brief Test of Adult Cognition by Telephone-BTACT screen PHQ-8 screen Caregiver Appraisal of Function and Upset CAFU Wisconsin Card Sorting Test Digi-Span Test Uptake questionnaire Coping Orientation to Problems Experienced-Brief Client Satisfaction Questionnaire General Self-Efficacy Scale Goal Attainment Scaling Feasibility data
Description of Intervention The intervention will consist of 6 sessions of PSTapproximately 30 minutes each that follow a structured format outlined in the PST manual The interventionist Osborne PI will facilitate the participants use of the steps of PST to develop specific action plans to overcome barriers to goal attainment while the participant receives rTMS or directly after the participant receives rTMS The investigators will deliver 10 Hz of rTMS to the left dorsolateral prefrontal cortex at 80 RMT with trains of 5-s duration 50 pulses per train 25-s inter-train intervals and a total of 40 trains 2000 pulses for the first 20 minutes of the PST session using the MagPro x100-MagVenture rTMS technology with a figure-8 coil9 The optimal stimulation parameters in this population have not been established The investigators intent is to excite the targeted neuro-circuitry therefore the investigators propose a frequency of 10Hz which has successfully stimulated the prefrontal cortex in patients with stroke in multiple studies A 2016 systematic review of rTMS for the treatment of depression after stroke included 24 studies Twenty-one of the studies targeted the prefrontal cortex and 10 of the studies employed a frequency of 10Hz A pooled analysis 881 patients randomized to the experimental group revealed a significant difference in headache occurrence between the experimental 15 patients17 and control groups 6 patients 07 There were no significant differences between groups for other adverse events or withdrawals as a result of adverse eventsTargeting method will use the international 10-20 system to locate specific brain targets This method has been validated in use in TMS research it maximizes targeting precision and individualizes to the subject head size and shape rTMS will be discontinued at 20 minutes regardless of PST session length
Research Design and Methods The investigators will conduct a feasibility pilot trial of PSTrTMS in 4 adults with chronic stroke --to assess if the intervention is acceptable to Client Satisfaction Questionnaire-8 and feasible for sessions completed percentage of rTMS intensity reductions individuals with executive function deficits after stroke and whether rTMS enhances 1 attention and immediate memory digit span 2 cognitive flexibility and reasoning Wisconsin Card Sorting Task and 3 uptake uptake questionnaire of the PST intervention to improve 4 self-efficacy General Self-Efficacy Scale 5 generalization Goal Attainment Scaling-trained vs untrained goals Brief Cope of the PST strategy and support long-term goal attainment Goal Attainment Scaling at 1 months Outcomes will be assessed at baseline completion of intervention and 1-months post
Sample Size 4 participants will be enrolled The pilot data from this study will provide the parameter estimates necessary to perform sample size determination for a future large randomized control trial
Data Collection The PI will perform set-up and application of the TMS coil and will administer the assessments at baseline visit 1- in person completion of intervention visit 6-in person and 1-months post intervention completion via RedCap link that is emailed to the participant or via phone call participants preference All intervention sessions will be audio-recorded to ensure fidelity Data will be stored in RedCap database
Primary Outcome Measures
Demographics Caregiver Appraisal of functional dependence modified Safety questionnaire for TMS Brief Test of Adult Cognition by Telephone-BTACT screen PHQ-8 screen Caregiver Appraisal of Function and Upset CAFU Wisconsin Card Sorting Test Digi-Span Test Uptake questionnaire Coping Orientation to Problems Experienced-Brief Client Satisfaction Questionnaire General Self-Efficacy Scale Goal Attainment Scaling Feasibility data
Description of Intervention The intervention will consist of 6 sessions of PSTapproximately 30 minutes each that follow a structured format outlined in the PST manual The interventionist Osborne PI will facilitate the participants use of the steps of PST to develop specific action plans to overcome barriers to goal attainment while the participant receives rTMS or directly after the participant receives rTMS The investigators will deliver 10 Hz of rTMS to the left dorsolateral prefrontal cortex at 80 RMT with trains of 5-s duration 50 pulses per train 25-s inter-train intervals and a total of 40 trains 2000 pulses for the first 20 minutes of the PST session using the MagPro x100-MagVenture rTMS technology with a figure-8 coil9 The optimal stimulation parameters in this population have not been established The investigators intent is to excite the targeted neuro-circuitry therefore the investigators propose a frequency of 10Hz which has successfully stimulated the prefrontal cortex in patients with stroke in multiple studies A 2016 systematic review of rTMS for the treatment of depression after stroke included 24 studies Twenty-one of the studies targeted the prefrontal cortex and 10 of the studies employed a frequency of 10Hz A pooled analysis 881 patients randomized to the experimental group revealed a significant difference in headache occurrence between the experimental 15 patients17 and control groups 6 patients 07 There were no significant differences between groups for other adverse events or withdrawals as a result of adverse eventsTargeting method will use the international 10-20 system to locate specific brain targets This method has been validated in use in TMS research it maximizes targeting precision and individualizes to the subject head size and shape rTMS will be discontinued at 20 minutes regardless of PST session length
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