Trial Outcomes & Findings for Repetitive TMS and Occupational Therapy in Children and Young Adults With Chronic Hemiparesis (NCT NCT02057276)

NCT ID: NCT02057276

Last Updated: 2017-03-14

Results Overview

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 2 participants
• Primary outcome timeframe: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT
• Results posted on: 2017-03-14

Participant Flow

After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.

Participant milestones

Measure	Active rTMS Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study. Occupational Therapy	Sham rTMS Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. Sham Repetitive Transcranial Magnetic Stimulation Occupational Therapy
Overall Study STARTED	0	0
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Repetitive TMS and Occupational Therapy in Children and Young Adults With Chronic Hemiparesis

Baseline characteristics by cohort

Measure	Active rTMS Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. Repetitive Transcranial Magnetic Stimulation: We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study. Occupational Therapy	Sham rTMS Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays. Sham Repetitive Transcranial Magnetic Stimulation Occupational Therapy	Total Total of all reporting groups
Sex: Female, Male Female	—	—	0 n=5 Participants
Sex: Female, Male Male	—	—	0 n=5 Participants

PRIMARY outcome

Timeframe: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT

Population: After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 7 days after rTMS/OT

Population: After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 12 weeks after rTMS/OT

Population: After signing consent forms, two separate participants did not proceed with the study. The study was then terminated.

Outcome measures

Outcome data not reported

Adverse Events

Active rTMS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham 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

Steve Wu, MD

Cincinnati Children's Hospital Medical Center

Phone: 513-636-4222

Email: steve.wu@cchmc.org

Results disclosure agreements

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