Trial Outcomes & Findings for TMS for CRPS - Pilot Study (NCT NCT01926119)

NCT ID: NCT01926119

Last Updated: 2017-05-10

Results Overview

Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 4 participants
• Primary outcome timeframe: Baseline to post-TMS day 5
• Results posted on: 2017-05-10

Participant Flow

Participant milestones

Measure	TMS Intervention - 5 Days Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation Transcranial Magnetic Stimulation
Overall Study STARTED	4
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	TMS Intervention - 5 Days Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation Transcranial Magnetic Stimulation
Overall Study Withdrawal by Subject	1

Baseline Characteristics

TMS for CRPS - Pilot Study

Baseline characteristics by cohort

Measure	TMS Intervention - 5 Days n=4 Participants Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation Transcranial Magnetic Stimulation
Age, Continuous	55.5 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Region of Enrollment United States	4 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to post-TMS day 5

Population: Completed 5 days of TMS

Numerical rating scale (NRS) where 0=no pain and 10=worst pain imaginable

Outcome measures

Measure	TMS Intervention - 5 Days n=3 Participants Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days. Transcranial Magnetic Stimulation
Change in Pain Baseline NRS	5.2 units on a scale Interval 3.6 to 7.2
Change in Pain Post-TMS day 5 NRS	0.7 units on a scale Interval 0.0 to 1.1

SECONDARY outcome

Timeframe: End of 5-day treatment series and at 1-week follow-up relative to baseline

Population: This data was not collected and was therefore not analyzed.

As assessed by functional capacity exam and physical exam

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: End of each treatment session and at 1-week follow-up as compared to baseline

Population: This data was not collected and therefore not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: End of each treatment session and at 1-week follow-up as compared to baseline

Population: This data was not collected and therefore not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: End of each treatment session and at 1-week follow-up as compared to baseline

Population: This data was not collected and therefore not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: End of each treatment session and at 1-week follow-up as compared to baseline

Population: This data was not collected and therefore not analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: End of each of the 5 treatment sessions and at 1-week follow-up relative to baseline

Population: This data was not collected and therefore not analyzed.

Outcome measures

Outcome data not reported

Adverse Events

TMS Intervention - 5 Days

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TMS Intervention - 5 Days n=4 participants at risk Application of Transcranial Magnetic Stimulation (TMS) once per day over 5 days in the order of Theta Burst Stimulation followed by High frequency stimulation Transcranial Magnetic Stimulation
Nervous system disorders Headache	75.0% 3/4 • Number of events 3 • Participants were followed during 5 days of treatment and for 1 week following treatment Participants were assessed for pain before and after each treatment session and at 1 week follow-up. During these assessments adverse events were evaluated as well.
Gastrointestinal disorders Nausea and vomiting	50.0% 2/4 • Number of events 2 • Participants were followed during 5 days of treatment and for 1 week following treatment Participants were assessed for pain before and after each treatment session and at 1 week follow-up. During these assessments adverse events were evaluated as well.

Additional Information

Kevin Johnson, PhD RN

Stanford University

Phone: (650) 721-1988

Email: johnsk@stanford.edu

Results disclosure agreements

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