Clinical trial NCT05017857: Feasibility of Problem Solving Training Paired With Transcranial Magnetic Stimulation
Official title: Exploring the Feasibility of Problem Solving Training Paired With Transcranial Magnetic Stimulation to Improve Problem-solving Skills After Stroke
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Stroke
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2021-08-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 1a:80% 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 PST+rTMS 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 PST+rTMS 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, participant's 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 PST(approximately 30 minutes each) that follow a structured format outlined in the PST manual. The interventionist (Osborne, PI) will facilitate the participant's 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 coil.9 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 patients,1.7%) and control groups (6 patients, 0.7%). There were no significant differences between groups for other adverse events or withdrawals as a result of adverse events.Targeting 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 6 months since stroke
* English fluency
* \>= 18 years old
* executive function deficits present (BTACT z-score based on age must fall between -1.3 and 1.3 SD)
* capacity of patient to self-consent.

Exclusion Criteria:

* severe aphasia (clinical judgement of inability to complete BTACT secondary to expressive/receptive aphasia)
* severe depression (Patient Health Questionnaire-8 \< 15)
* self-reported dementia diagnosis, (4) contraindications of rTMS such as pacemaker implantation, history of epilepsy, major head trauma or seizures
* use of pharmacologic agents targeting stroke-related cognitive deficits.

All subjects must be screened for contraindications to TMS before any TMS can be performed. Subjects will be screened for known risk factors for seizure with rTMS using the TMS Adult Safety Screen (TASS) questionnaire.

Primary outcomes:
measure: Total number of sessions completed
timeFrame: Baseline to 1 month followup
measure: Client Satisfaction Questionnaire-8 (CSQ-8) item mean score
timeFrame: Baseline to 1 month followup
measure: Changes in coping style as measured by the Coping Orientation to Problems Experienced-Brief (Brief Cope)
timeFrame: Baseline to 1 month followup
measure: Percentage of attained goals using Goal Attainment Scaling (GAS)
timeFrame: Baseline to 1 month followup
measure: PST session completed or not
timeFrame: baseline to up to 8 weeks
measure: Reasons for non-completion
timeFrame: baseline up to 8 weeks
measure: Need to reduce rTMS intensity
timeFrame: baseline up to 8 weeks
measure: report of side effects
timeFrame: baseline up to 8 weeks
Secondary outcomes:
measure: Changes in general self efficacy as measured by the General self-efficacy scale (GSE)
timeFrame: baseline to 1 month follow-up
measure: Measure of intervention uptake as measured by the uptake questionnaire
timeFrame: baseline up to 8 weeks
measure: Changes in attention and working memory as measured by the Digi-Span Test
timeFrame: baseline up to 8 weeks
measure: Changes in executive function as measured by the Wisconsin Card Sorting Test (WCST)
timeFrame: baseline up to 8 weeks
Other outcomes:
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