Repetitive TMS and Occupational Therapy in Children and Young Adults With Chronic Hemiparesis
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ClinicalTrials.gov Identifier: NCT02057276 |
Recruitment Status :
Terminated
(Study was terminated due to low recruitment.)
First Posted : February 7, 2014
Results First Posted : August 3, 2015
Last Update Posted : March 14, 2017
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Condition or disease | Intervention/treatment | Phase |
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Pediatric Stroke Cerebral Palsy Chronic Hemiparesis | Device: Repetitive Transcranial Magnetic Stimulation Device: Sham Repetitive Transcranial Magnetic Stimulation Other: Occupational Therapy | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Motor Control Enhancement Through Repetitive Transcranial Magnetic Stimulation Plus Rehabilitation in Hemiparetic Cerebral Palsy and Stroke |
Study Start Date : | September 2012 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2016 |

Arm | Intervention/treatment |
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Active Comparator: Active rTMS
Participants will receive daily active rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
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Device: Repetitive Transcranial Magnetic Stimulation
We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study. Other: Occupational Therapy |
Sham Comparator: Sham rTMS
Participants will receive daily sham rTMS with occupational therapy immediately following rTMS for 10 consecutive weekdays.
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Device: Sham Repetitive Transcranial Magnetic Stimulation Other: Occupational Therapy |
- Change in the "Melbourne Assessment of Unilateral Upper Limb Function" [ Time Frame: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 3 days after rTMS/OT ]
- Change in the "Melbourne Assessment of Unilateral Upper Limb Function" [ Time Frame: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 7 days after rTMS/OT ]
- Change in the "Melbourne Assessment of Unilateral Upper Limb Function" [ Time Frame: Change in the "Melbourne Assessment of Unilateral Upper Limb Function" between baseline and 12 weeks after rTMS/OT ]

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Ages Eligible for Study: | 10 Years to 20 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age ≥ 10 years; < 21 years
- Hemiparesis
- Manual Ability Classification System (MACS) level I through IV
- Provision of written informed consent by the patient and/or guardian, including understanding that insurance may be billed for the occupational therapy
- Written assent form signed by participants younger than 18 years of age
Exclusion Criteria:
- Underlying degenerative or metabolic disorder or supervening medical illness
- Severe depression or other psychiatric disorder
- Any participant who is pregnant
- Any contraindication to TMS (i.e., intracranial metal implants, shunts, ports, pacemaker, baclofen pumps)
- Any changes or addition of neuropsychiatric medications within 1 month of starting the study or during course of the study (if applicable)
- Any botulinum toxin (Botox, Myobloc) or phenol injection within the last 3 months prior to the study or during the course of the study (if applicable)
- Any upper extremity surgery within the last 6 months prior to the study or scheduled during the course of the study (if applicable)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057276
United States, Ohio | |
Cincinnati Children's Hospital Medical Center | |
Cincinnati, Ohio, United States, 45229 |
Principal Investigator: | Steve W Wu, MD | Children's Hospital Medical Center, Cincinnati |
Responsible Party: | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT02057276 |
Other Study ID Numbers: |
CIN001 - rTMS/hemiparesis 2012-1533 ( Other Identifier: Cincinnati Children's Hospital Medical Center ) |
First Posted: | February 7, 2014 Key Record Dates |
Results First Posted: | August 3, 2015 |
Last Update Posted: | March 14, 2017 |
Last Verified: | February 2017 |
Cerebral Palsy Paresis Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Brain Damage, Chronic Neurologic Manifestations |