StrokeNCT05017857
Feasibility of Problem Solving Training Paired With Transcranial Magnetic Stimulation
A study testing RepetiveTranscrainal Magnetic Stimulation (rTMS) and Problem-Solving Training (PST) in people with Stroke, run by University of Texas Southwestern Medical Center.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- RepetiveTranscrainal Magnetic Stimulation (rTMS) and Problem-Solving Training (PST)
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2022to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
About this study
Official title: Exploring the Feasibility of Problem Solving Training Paired With Transcranial Magnetic Stimulation to Improve Problem-solving Skills After Stroke
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- RepetiveTranscrainal Magnetic Stimulation (rTMS), Problem-Solving Training (PST)
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RepetiveTranscrainal Magnetic Stimulation (rTMS)Device
RepetiveTranscrainal Magnetic Stimulation (rTMS): rTMS is a non-invasive electromagnetic stimulation of the brain. A train of electric pulses is delivered at the same intensity over a set period of time to a targeted region of the brain. The current stimulates or suppresses neuronal activity based on the frequency and inter-train interval between the pulses.
Problem-Solving Training (PST)Behavioural
Problem-Solving Training (PST) is a metacognitive strategy training in which patients are guided through a process of conscious self-assessment resulting in problem identification, generation of solutions, development of specific goals and action plans, and evaluation and revision of plans as needed. PST thus helps to circumvent impulsive or unrealistic problem-solving attempts that lead to failure, discouragement, and feelings of helplessness.
| Study group | Role | What they receive |
|---|---|---|
| Simultaneous rTMS and PST | Experimental | Not described Receives: Device: RepetiveTranscrainal Magnetic Stimulation (rTMS); Behavioral: Problem-Solving Training (PST) |
| Sequential rTMS and PST | Experimental | Not described Receives: Device: RepetiveTranscrainal Magnetic Stimulation (rTMS); Behavioral: Problem-Solving Training (PST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total number of sessions completed
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.
Measured: Baseline to 1 month followup
Client Satisfaction Questionnaire-8 (CSQ-8) item mean score
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.
Measured: Baseline to 1 month followup
Changes in coping style as measured by the Coping Orientation to Problems Experienced-Brief (Brief Cope)
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.
Measured: Baseline to 1 month followup
Percentage of attained goals using Goal Attainment Scaling (GAS)
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)
Measured: Baseline to 1 month followup
PST session completed or not
The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential).
yes or no
Measured: baseline to up to 8 weeks
Reasons for non-completion
The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential).
descriptive, no scores
Measured: baseline up to 8 weeks
Need to reduce rTMS intensity
The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential).
yes or no
Measured: baseline up to 8 weeks
report of side effects
The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential).
yes or no
Measured: baseline up to 8 weeks
Secondary outcomes (4)
Changes in general self efficacy as measured by the General self-efficacy scale (GSE)
The GSE is a 10 item self-report measure of self-efficacy. Internal reliability for GSE = Cronbach's alphas between .76 and .90. The scale is designed to measure self-efficacy specifically as it relates to coping with stressful daily events. Scores range from 10 to 40. Higher score indicates more self efficacy.
Measured: baseline to 1 month follow-up
Measure of intervention uptake as measured by the uptake questionnaire
A Likert scale assessment that the study team developed and has used in previous PST studies. (1) How confident do you feel using the PST strategy? (2) How confident do you feel that you will be able to apply the PST strategy to other problems now that the sessions are over? (3) How many sessions do you think it took before you felt confident using the PST strategy?
Measured: baseline up to 8 weeks
Changes in attention and working memory as measured by the Digi-Span Test
The Digit Span Test is a subtest of the Wechsler Adult Intelligence Scale and the Wechsler Memory Scale. Forward span captures attention efficiency and capacity. Backward span is an executive task dependent of working memory.
Measured: baseline up to 8 weeks
Changes in executive function as measured by the Wisconsin Card Sorting Test (WCST)
The WCST measures ability to shift cognitive strategies in response to a changing environment as well of executive function (planning, organized searching, utilizing environmental feedback, directing behavior towards achieving a goal, and modulating impulsive response. This assessment has been validated in the stroke population.
Measured: baseline up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study startJan 2022 (estimated)
- Primary completionSep 2022 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Study PI is leaving the institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Candice Osborne, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05017857
- Sponsor's protocol ID
- UTSW 2021-0003
- Status last verified
- Feb 2022
- First submitted
- 27 Jul 2021
- Last updated
- 28 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of Problem Solving Training Paired With Transcranial Magnetic Stimulation to Improve Problem-solving Skills After Stroke
- ClinicalTrials.gov ID
- NCT05017857
- Acronym / sponsor ID
- UTSW 2021-0003
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study PI is leaving the institution.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Jan 2022 (estimated)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 24 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simultaneous rTMS and PST | Experimental | Device: RepetiveTranscrainal Magnetic Stimulation (rTMS), Behavioral: Problem-Solving Training (PST) |
| Sequential rTMS and PST | Experimental | Device: RepetiveTranscrainal Magnetic Stimulation (rTMS), Behavioral: Problem-Solving Training (PST) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RepetiveTranscrainal Magnetic Stimulation (rTMS)RepetiveTranscrainal Magnetic Stimulation (rTMS): rTMS is a non-invasive electromagnetic stimulation of the brain. A train of electric pulses is delivered at the same intensity over a set period of time to a targeted region of the brain. The current stimulates or suppresses neuronal activity based on the frequency and inter-train interval between the pulses. | Device | Sequential rTMS and PST, Simultaneous rTMS and PST |
| Problem-Solving Training (PST)Problem-Solving Training (PST) is a metacognitive strategy training in which patients are guided through a process of conscious self-assessment resulting in problem identification, generation of solutions, development of specific goals and action plans, and evaluation and revision of plans as needed. PST thus helps to circumvent impulsive or unrealistic problem-solving attempts that lead to failure, discouragement, and feelings of helplessness. | Behavioural | Sequential rTMS and PST, Simultaneous rTMS and PST |
Primary outcome
Total number of sessions completed
Time frame: 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
Time frame: 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)
Time frame: 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.
Percentage of attained goals using Goal Attainment Scaling (GAS)
Time frame: 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)
PST session completed or not
Time frame: baseline to up to 8 weeks
The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential). yes or no
Reasons for non-completion
Time frame: baseline up to 8 weeks
The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential). descriptive, no scores
Need to reduce rTMS intensity
Time frame: baseline up to 8 weeks
The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential). yes or no
report of side effects
Time frame: baseline up to 8 weeks
The investigators will descriptively compare results of PST+rTMS(simultaneous) to PST +rTMS(sequential). yes or no
4 secondary outcomes
Changes in general self efficacy as measured by the General self-efficacy scale (GSE)
Time frame: baseline to 1 month follow-up
Measure of intervention uptake as measured by the uptake questionnaire
Time frame: baseline up to 8 weeks
Changes in attention and working memory as measured by the Digi-Span Test
Time frame: baseline up to 8 weeks
Changes in executive function as measured by the Wisconsin Card Sorting Test (WCST)
Time frame: baseline up to 8 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing RepetiveTranscrainal Magnetic Stimulation (rTMS) and Problem-Solving Training (PST) in people with Stroke, run by University of Texas Southwestern Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total number of sessions completed (time frame: Baseline to 1 month followup). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022; AzTrials last refreshed its copy on 6 Nov 2026.