Clinical trial NCT02914418: Transcranial Magnetic Stimulation (TMS) for Upper Limb Dysfunction in Spinal Cord Injury: a Feasibility Study
Official title: Feasibility Study to Investigate the Effects of Transcranial Magnetic Stimulation (TMS) Using Theta Burst Stimulation (TBS) to Treat Upper Limb Dysfunction and Spasticity in Patients With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: transcranial magnetic stimulation
Spinal Cord Injuries
Muscle Spasticity
Pain
Spinal Cord
Spinal Cord Diseases
Lead sponsor: Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-09-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will investigate how repetitive transcranial magnetic stimulation (TMS) using intermittent theta-burst stimulation (iTBS) paradigm affects sensorimotor dysfunction such as pain, spasticity, motor weakness and sensory loss. TMS is technique which allows non-invasive stimulation of the cortex, and can modulate activity of neurons. The purpose of this study will be to assess the feasibility of using TMS with iTBS paradigm to treat sensorimotor dysfunction in people with incomplete spinal cord injury affecting the upper limbs.


Eligibility criteria: Inclusion Criteria:

* Aged 18-70 years old inclusive
* Traumatic and non-traumatic tetraplegic patient following chronic incomplete (AIS C or D) SCI injury (sustained at least three months ago)
* Referred to the Sheffield Spinal Injuries Centre
* Be able to provide written informed consent or verbal consent in the presence of an independent witness
* Spasticity affecting upper limbs with a Modified Ashworth scale (MAS) 2 or above
* Stable medical treatment for at least 1 week before and 1 week after TMS application
* Stable medical condition

Exclusion Criteria:

* Aged less than 18 years old
* Lack the mental capacity to consent
* Ventilated patients with sedation
* Very acute (\<3 months) SCI patients
* Implanted electrical devices such as pacemakers, Concomitant neurological conditions, including any history of epilepsy
* Significant joint-related limitation of passive range of movement
* Unable to attend all TMS sessions
* Pregnancy
* Inability to tolerate TBS
* Significant upper limb contractures

Primary outcomes:
measure: Feasibility Criteria 1: Number of participants recruited
timeFrame: Through to study completion, up to 6 months
measure: Feasibility Criteria 2: Number of participants completing intervention protocol
timeFrame: Through to study completion, up to 6 months
measure: Feasibility Criteria 3: Number of Valid data sets
timeFrame: Through to study completion, up to 6 months
measure: Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants
timeFrame: Through to study completion, up to 6 months
Secondary outcomes:
measure: Modified Ashworth Scale (MAS)
timeFrame: Baseline and 2 weeks
measure: Range of Motion (RoM)
timeFrame: Baseline and 2 weeks
measure: Leeds Arm Spasticity Impact Scale (LASIS)
timeFrame: Baseline and 2 weeks
measure: Visual Analogue Scale (Spasticity) (VAS-S)
timeFrame: Baseline and 2 weeks
measure: American Spinal Injuries Association Impairment Scale (AIS) (Inc. grading, upper extremity motor score, lower extremity motor score, light touch and pin prick scores)
timeFrame: Baseline and 2 weeks
measure: Spinal Cord Independence Measure (SCIM) - Version 3
timeFrame: Baseline and 2 weeks
measure: Visual Analogue Scale (Pain) - (VAS-P)
timeFrame: Baseline and 2 weeks
Other outcomes:
Locations:
city: Sheffield
country: United Kingdom
facility: Princess Royal Spinal Injuries Centre, Northern General Hospital.
state: South Yourkshire
Study officials:
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
name: Ram Hariharan, MD
role: STUDY_CHAIR
affiliation: Sheffield Teaching Hospital NHS Foundation Trust. University of Sheffield.
name: Ali Gharooni
role: PRINCIPAL_INVESTIGATOR
References: