Trial · NCT02208466
Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients
NCT02208466, Phase 2, Completed, Spaulding Rehabilitation Hospital; results first posted 2021-02-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients. Trials, record NCT02208466. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02208466
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects rTMS Combined With Fluoxetine on Motor Recovery in Stroke Patients
- NCT number
- NCT02208466
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 44 participants, actual
- Lead sponsor
- Spaulding Rehabilitation Hospital
- Conditions
- Stroke, Motor Function
- Interventions
- Active Repetitive Transcranial Magnetic Stimulation (rTMS), Fluoxetine, Sham repetitive transcranial magnetic stimulation (rTMS), Placebo Fluoxetine
- First posted
- 2014-08-05
- Last updated
- 2021-02-21
- Results first posted
- 2021-02-21
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Motor Function (Jebsen-Taylor Task) | baseline and 90 days | Jebsen Taylor Hand Function Test: measures hand function in real-life activities, by evaluating the time required to perform 7 different tasks. We used the non-constrained hand for the assessments. The sum of the different tasks was used for the analysis. Calculation details: value at 9 months minus value at baseline, change in seconds (adjusted mean difference). |
| Primary | Changes in Fugl-Meyer Assessment (FMA) Scale | baseline and 90 days | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. We used the upper limb motor function subscale: minimum values= 0 ; maximum values= 66. Higher scores mean a better outcome. Changes from baseline to 90 days (value at 90 days minus value at baseline). |
| Secondary | Changes in Cortical Excitability Measures | Baseline and 90 days | We will measure cortical excitability using single-pulsed transcranial magnetic stimulation (TMS) before and after stimulation at three different time-points. Changes from baseline to 90 days (value at 90 days minus value at baseline). |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in Motor Function (Jebsen-Taylor Task) | baseline and 90 days | Performed by a rater blinded to rTMS and pharmacotherapy performed all assessments | seconds | MEAN |
| PRIMARY | Changes in Fugl-Meyer Assessment (FMA) Scale | baseline and 90 days | Performed by a rater blinded to rTMS and pharmacotherapy performed all assessments | units on a scale | MEAN |
| SECONDARY | Changes in Cortical Excitability Measures | Baseline and 90 days | Performed by a rater blinded to rTMS and pharmacotherapy performed all assessments | motor evoked potential (mV) | MEAN |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in Motor Function (Jebsen-Taylor Task) | Active rTMS/Active Fluoxetine | -214.33 | 95% Confidence Interval -289.32 to -139.35 | seconds | |
| Changes in Motor Function (Jebsen-Taylor Task) | Sham rTMS/Active Fluoxetine | -50.16 | 95% Confidence Interval -110.56 to -10.24 | seconds | |
| Changes in Motor Function (Jebsen-Taylor Task) | Sham rTMS/Placebo Fluoxetine | -117.98 | 95% Confidence Interval -197.39 to -38.58 | seconds | |
| Changes in Fugl-Meyer Assessment (FMA) Scale | Active rTMS/Active Fluoxetine | 10.10 | 95% Confidence Interval 4.06 to 16.14 | units on a scale | |
| Changes in Fugl-Meyer Assessment (FMA) Scale | Sham rTMS/Active Fluoxetine | 6.73 | 95% Confidence Interval 1.28 to 12.17 | units on a scale | |
| Changes in Fugl-Meyer Assessment (FMA) Scale | Sham rTMS/Placebo Fluoxetine | 15.55 | 95% Confidence Interval 9.16 to 21.95 | units on a scale | |
| Changes in Cortical Excitability Measures | Active rTMS/Active Fluoxetine | -0.05 | 95% Confidence Interval -0.34 to 0.08 | motor evoked potential (mV) | |
| Changes in Cortical Excitability Measures | Sham rTMS/Active Fluoxetine | -0.12 | 95% Confidence Interval -0.33 to 0.43 | motor evoked potential (mV) | |
| Changes in Cortical Excitability Measures | Sham rTMS/Placebo Fluoxetine | 0.33 | 95% Confidence Interval 0.07 to 1.16 | motor evoked potential (mV) |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Active rTMS/Active Fluoxetine | 9 | |
| Overall Study | STARTED | Sham rTMS/Active Fluoxetine | 10 | |
| Overall Study | STARTED | Sham rTMS/Placebo Fluoxetine | 8 | |
| Overall Study | COMPLETED | Active rTMS/Active Fluoxetine | 9 | |
| Overall Study | COMPLETED | Sham rTMS/Active Fluoxetine | 10 | |
| Overall Study | COMPLETED | Sham rTMS/Placebo Fluoxetine | 8 | |
| Overall Study | NOT COMPLETED | Active rTMS/Active Fluoxetine | 0 | |
| Overall Study | NOT COMPLETED | Sham rTMS/Active Fluoxetine | 0 | |
| Overall Study | NOT COMPLETED | Sham rTMS/Placebo Fluoxetine | 0 |
Source ClinicalTrials.gov
Adverse events3
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Active rTMS/Active Fluoxetine | 2 | 9 | 3 |
| other | Headache | Nervous system disorders | Sham rTMS/Active Fluoxetine | 0 | 10 | 0 |
| other | Headache | Nervous system disorders | Sham rTMS/Placebo Fluoxetine | 3 | 8 | 6 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Active rTMS/Active Fluoxetine | 0 | 9 |
| Total, all-cause mortality | Sham rTMS/Active Fluoxetine | 0 | 10 |
| Total, all-cause mortality | Sham rTMS/Placebo Fluoxetine | 0 | 8 |
| Total, other adverse events | Active rTMS/Active Fluoxetine | 2 | 9 |
| Total, other adverse events | Sham rTMS/Active Fluoxetine | 0 | 10 |
| Total, other adverse events | Sham rTMS/Placebo Fluoxetine | 3 | 8 |
| Total, serious adverse events | Active rTMS/Active Fluoxetine | 0 | 9 |
| Total, serious adverse events | Sham rTMS/Active Fluoxetine | 0 | 10 |
| Total, serious adverse events | Sham rTMS/Placebo Fluoxetine | 0 | 8 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31286828 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02208466
GET https://conductscience.org/api/trials/v1/NCT02208466/registered