Trial · NCT02427646
Kinematic-guided BoNT-A Treatment for ET and PD Tremor
NCT02427646, Phase 2, Unknown, Western University, Canada; results first posted 2019-08-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Kinematic-guided BoNT-A Treatment for ET and PD Tremor. Trials, record NCT02427646. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02427646
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Kinematic-guided BoNT-A Treatment for ET and PD Tremor
- NCT number
- NCT02427646
- Status
- Unknown
- Phases
- Phase 2
- Enrollment
- 54 participants, actual
- Lead sponsor
- Western University, Canada
- Conditions
- Tremor
- Interventions
- BoNT-A
- First posted
- 2015-04-28
- Last updated
- 2019-08-20
- Results first posted
- 2019-08-20
- Limitations and caveats
A specialized quality of life relating to tremor in PD participants would be more appropriate due to other symptoms PD patients experience. Blinded studies are not possible as muscle weakness can be easily recognized by patients and investigators
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Clinical Tremor Rating Scale (Fahn-Tolosa-Marin Tremor Rating Scale) | 0 to 96 weeks | Improvement in hand tremor as determined by a reduction of \>8 points on a standardized clinical assessment tool (Fahn-Tolosa-Marin Tremor Assessment Scale) pre and post Xeomin® injection using kinematic guided injection parameters for both IPD and ET. Lower scores indicate a better outcome. Means and standard deviations are provided in the data tables. FTM minimum and maximum scores range from 0 to 92 FTM points. |
| Secondary | Kinematic Tremor Severity | 96 weeks | For two subgroups of participants: (A) those with a \> 8 point improvement on the tremor rating scale and (B) those with a change ≤ 8 points on the tremor rating scale, Group A will have 50% reduction in overall tremor amplitude as measured by kinematics. Kinematic measures were graphically represented as mean angular RMS amplitude and standard deviations of the population at the wrist over three trials during scripted task. Kinematic tremor analysis is shown in angular root mean square (RMS) amplitudes |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Clinical Tremor Rating Scale (Fahn-Tolosa-Marin Tremor Rating Scale) | 0 to 96 weeks | Mean total FTM score was compared from baseline to each time-point. Here we state the baseline and final visit scores per group | scores on total FTM scale | MEAN |
| SECONDARY | Kinematic Tremor Severity | 96 weeks | Mean kinematic tremor amplitude was compared from baseline to each time-point. Here we state the baseline and final visit tremor amplitudes per group | Angular root mean square amplitude | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Clinical Tremor Rating Scale (Fahn-Tolosa-Marin Tremor Rating Scale) | Essential Tremor Treatment | Week 0 | 30.6 | Standard Deviation 5.5 | scores on total FTM scale |
| Clinical Tremor Rating Scale (Fahn-Tolosa-Marin Tremor Rating Scale) | Parkinson Disease Tremor Treatment | Week 0 | 19.4 | Standard Deviation 2.7 | scores on total FTM scale |
| Clinical Tremor Rating Scale (Fahn-Tolosa-Marin Tremor Rating Scale) | Essential Tremor Treatment | Week 96 | 14.9 | Standard Deviation 3.5 | scores on total FTM scale |
| Clinical Tremor Rating Scale (Fahn-Tolosa-Marin Tremor Rating Scale) | Parkinson Disease Tremor Treatment | Week 96 | 14.1 | Standard Deviation 3.4 | scores on total FTM scale |
| Kinematic Tremor Severity | ET BoNT-A Treatment | Week 0 | 0.73 | Standard Deviation 0.69 | Angular root mean square amplitude |
| Kinematic Tremor Severity | PD Tremor BoNT-A Treatment | Week 0 | 1.04 | Standard Deviation 0.27 | Angular root mean square amplitude |
| Kinematic Tremor Severity | ET BoNT-A Treatment | Week 96 | 0.15 | Standard Deviation 0.26 | Angular root mean square amplitude |
| Kinematic Tremor Severity | PD Tremor BoNT-A Treatment | Week 96 | 0.33 | Standard Deviation 0.11 | Angular root mean square amplitude |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Essential Tremor Treatment | 24 | |
| Overall Study | STARTED | Parkinson Disease Tremor Treatment | 28 | |
| Overall Study | COMPLETED | Essential Tremor Treatment | 16 | |
| Overall Study | COMPLETED | Parkinson Disease Tremor Treatment | 14 | |
| Overall Study | NOT COMPLETED | Essential Tremor Treatment | 8 | |
| Overall Study | NOT COMPLETED | Parkinson Disease Tremor Treatment | 14 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Essential Tremor Treatment | 0 | 24 |
| Total, all-cause mortality | Parkinson Disease Tremor Treatment | 0 | 28 |
| Total, other adverse events | Essential Tremor Treatment | 0 | 24 |
| Total, other adverse events | Parkinson Disease Tremor Treatment | 0 | 28 |
| Total, serious adverse events | Essential Tremor Treatment | 0 | 24 |
| Total, serious adverse events | Parkinson Disease Tremor Treatment | 0 | 28 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Essential Tremor Treatment vs Parkinson Disease Tremor Treatment: deaths from any cause | Trial comparisons |
| Essential Tremor Treatment vs Parkinson Disease Tremor Treatment: serious adverse events | Trial comparisons |
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/NCT02427646
GET https://conductscience.org/api/trials/v1/NCT02427646/registered