Exploring the Feasibility of Problem Solving Training Paired With Transcranial Magnetic Stimulation to Improve Problem-solving Skills After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- report of side effects
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 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.
排除标准
- •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.
研究组 & 干预措施
Sequential rTMS and PST
干预措施: RepetiveTranscrainal Magnetic Stimulation (rTMS) (Device)
Sequential rTMS and PST
干预措施: Problem-Solving Training (PST) (Behavioral)
Simultaneous rTMS and PST
干预措施: RepetiveTranscrainal Magnetic Stimulation (rTMS) (Device)
Simultaneous rTMS and PST
干预措施: Problem-Solving Training (PST) (Behavioral)
结局指标
主要结局
report of side effects
时间窗: baseline up to 8 weeks
The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential). yes or no
Percentage of attained goals using Goal Attainment Scaling (GAS)
时间窗: Baseline to 1 month followup
To test the second hypothesis, the investigators will calculate the total percentage of attained goals (Goal Attainment Scaling outcome level \>"as expected") out of all attempted goals for each participant. GAS is a method for developing patient-centered goals and measuring goal achievement. GAS has been found to be a valid, reliable and sensitive measure of goal attainment in an IRU population. GAS scale (-2, achieved less than expected outcome; -1, achieved somewhat less; 0, achieved expected level; +1, achieved somewhat more; +2, achieved much more)
Reasons for non-completion
时间窗: baseline up to 8 weeks
The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential). descriptive, no scores
Total number of sessions completed
时间窗: Baseline to 1 month followup
The primary outcome to assess feasibility is total number of sessions completed, with a threshold of 90% completing a minimum of 6 sessions at the specified rTMS intensity as an indicator of feasibility.
Client Satisfaction Questionnaire-8 (CSQ-8) item mean score
时间窗: Baseline to 1 month followup
The primary outcome for acceptability is satisfaction, with a Client Satisfaction Questionnaire-8 item mean of \>3.5 as an indicator of high satisfaction. CSQ-8 is a standardized assessment of client satisfaction with an intervention. Scores range from 8-32. A higher scores indicates a better outcome.
Changes in coping style as measured by the Coping Orientation to Problems Experienced-Brief (Brief Cope)
时间窗: Baseline to 1 month followup
To test the first hypothesis, the investigators will use intent-to-treat analyses to measure pre-post-test differences in coping between baseline and final intervention session using paired t-tests or Wilcoxon signed rank test. The Brief Cope is a 28 item self-reported questionnaire that measures effective and ineffective ways to cope with life events that cause stress. The assessment measures the degree to which a person utilizes a specific coping strategy.
Need to reduce rTMS intensity
时间窗: baseline up to 8 weeks
The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential). yes or no
PST session completed or not
时间窗: baseline to up to 8 weeks
The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential). yes or no
次要结局
- Changes in attention and working memory as measured by the Digi-Span Test(baseline up to 8 weeks)
- Changes in executive function as measured by the Wisconsin Card Sorting Test (WCST)(baseline up to 8 weeks)
- Measure of intervention uptake as measured by the uptake questionnaire(baseline up to 8 weeks)
- Changes in general self efficacy as measured by the General self-efficacy scale (GSE)(baseline to 1 month follow-up)
研究者
Candice Osborne
Assistant Professor
University of Texas Southwestern Medical Center