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Trial Outcomes & Findings for A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential Tremor (NCT NCT02763865)

NCT ID: NCT02763865

Last Updated: 2019-02-15

Results Overview

Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

10 participants

Primary outcome timeframe

Baseline (Visit 2) post intervention

Results posted on

2019-02-15

Participant Flow

clinic

screening procedures per inclusion and exclusion criteria, no wash out, stayed on meds.

Participant milestones

Participant milestones
Measure
Active
Active pre-SMA rTMS
Sham
sham tms
Overall Study
STARTED
5
5
Overall Study
COMPLETED
5
5
Overall Study
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Pilot Study to Assess the Effects of Pre-SMA LF-rTMS for the Treatment of Essential Tremor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Active
n=5 Participants
active tms
Sham
n=5 Participants
sham tms
Total
n=10 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Age, Categorical
>=65 years
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Age, Continuous
71.6 years
STANDARD_DEVIATION 12.17 • n=5 Participants
71.6 years
STANDARD_DEVIATION 12.17 • n=7 Participants
71.6 years
STANDARD_DEVIATION 12.17 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
3 Participants
n=7 Participants
6 Participants
n=5 Participants
Sex: Female, Male
Male
2 Participants
n=5 Participants
2 Participants
n=7 Participants
4 Participants
n=5 Participants
Region of Enrollment
United States
5 participants
n=5 Participants
5 participants
n=7 Participants
10 participants
n=5 Participants
Mean TRS at Baseline Visit
36.0 units on a scale
STANDARD_DEVIATION 8.276 • n=5 Participants
34 units on a scale
STANDARD_DEVIATION 5.385 • n=7 Participants
35 units on a scale
STANDARD_DEVIATION 6.667 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Visit 2) post intervention

Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)

Outcome measures

Outcome measures
Measure
Active
n=5 Participants
Sham
n=5 Participants
Mean TRS (Tremor Rating Score)
26.6 units on a scale
Standard Deviation 7.701
27.6 units on a scale
Standard Deviation 8.325

PRIMARY outcome

Timeframe: 4 week followup(visit 18)

Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)

Outcome measures

Outcome measures
Measure
Active
n=5 Participants
Sham
n=5 Participants
Mean TRS (Tremor Rating Score) at 4 Week Followup
29.60 units on a scale
Standard Deviation 9.555
29.2 units on a scale
Standard Deviation 5.891

PRIMARY outcome

Timeframe: 8 week followup (visit 19)

Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)

Outcome measures

Outcome measures
Measure
Active
n=5 Participants
Sham
n=5 Participants
Mean TRS (Tremor Rating Score) at 8 Week Followup
29.6 units on a scale
Standard Deviation 9.555
29.6 units on a scale
Standard Deviation 5.771

PRIMARY outcome

Timeframe: 12-week followup(visit 20)

Participants will be videotaped as they are being examined for the purpose of rating their tremor for the TRS. TRS scale is a range of 0 - 84 (0 being the least severe and 84 being the most severe tremor)

Outcome measures

Outcome measures
Measure
Active
n=5 Participants
Sham
n=5 Participants
Mean TRS (Tremor Rating Score) at 12 Week Followup
32.8 units on a scale
Standard Deviation 7.294
29.6 units on a scale
Standard Deviation 8.264

Adverse Events

Active Pre-SMA rTMS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Sham Pre-SMA rTMS

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gonzalo REvuelta

Medical University of South Carolina

Phone: 843-792-7262

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place