Transcranial Magnetic Stimulation (TMS) for Upper Limb Dysfunction in Spinal Cord Injury: a Feasibility Study

Spinal Cord Injuries Clinical Trial

— TUSI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02914418
• Other study ID #: STH18997
• Status: Completed
• Phase: N/A
• First received: August 23, 2016
• Last updated: May 4, 2017
• Start date: January 2016
• Est. completion date: September 2016

Study information

• Verified date: May 2017
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

Device:
• Transcranial Magnetic Stimulation using iTBS Paradigm
TMS is a non-invasive, painless method of stimulating the central and peripheral nervous system. ITBS is a form of TMS which is delivered for ~200sec and can promote changes in neural activity.

Locations

Country	Name	City	State
United Kingdom	Princess Royal Spinal Injuries Centre, Northern General Hospital.	Sheffield	South Yourkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility Criteria 1: Number of participants recruited	Recruitment of 20 participants within 6 months (i.e. 3 - 4 participants per month)	Through to study completion, up to 6 months
Primary	Feasibility Criteria 2: Number of participants completing intervention protocol	10 participants completing full intervention protocol	Through to study completion, up to 6 months
Primary	Feasibility Criteria 3: Number of Valid data sets	10 complete valid data sets	Through to study completion, up to 6 months
Primary	Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants	No serious adverse events	Through to study completion, up to 6 months
Secondary	Modified Ashworth Scale (MAS)	MAS is a clinical assessment of spasticity. Spasticity of wrist extensors, flexors, elbow extensors and flexors of both upper limbs will be assessed.	Baseline and 2 weeks
Secondary	Range of Motion (RoM)	Active RoM of wrist extension, flexion, elbow extension and flexion of both of both upper limbs will be measured using a goniometer.	Baseline and 2 weeks
Secondary	Leeds Arm Spasticity Impact Scale (LASIS)	Questionnaire assessing impact of spasticity on a person.	Baseline and 2 weeks
Secondary	Visual Analogue Scale (Spasticity) (VAS-S)	A 100mm line with two statements at each end (No spasticity, worst spasticity). The patient will mark on the line their own perception of how bad they feel their spasticity is.	Baseline and 2 weeks
Secondary	American Spinal Injuries Association Impairment Scale (AIS) (Inc. grading, upper extremity motor score, lower extremity motor score, light touch and pin prick scores)	A clinical assessment of sensory dermatomes and key muscle groups of upper and lower limbs.	Baseline and 2 weeks
Secondary	Spinal Cord Independence Measure (SCIM) - Version 3	scale developed to address the ability of SCI patients to perform basic activities of daily living independently.	Baseline and 2 weeks
Secondary	Visual Analogue Scale (Pain) - (VAS-P)	A 100mm line with two statements at each end (no pain, worst pain). The patient will mark on the line their own perception of how bad they feel their pain is.	Baseline and 2 weeks