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Trial record 19 of 1359 for:    transcranial magnetic stimulation

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

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ClinicalTrials.gov Identifier: NCT02914418
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : May 5, 2017
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Device: Transcranial Magnetic Stimulation using iTBS Paradigm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : January 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active iTBS
iTBS will be delivered using the 50Hz, 600 pulses protocol for 10 sessions over a period of two weeks. The hand representation of the primary motor cortex will targeted using a circular coil held over the vertex of skull. Intensity will be set to 80% of Resting Motor Threshold (RMT), which will be determined visually by the lowest percentage of stimulator output which can cause upper limb motor twitch in at least 5 out of 10 attempts.
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.
Other Name: repetitive Transcranial Magnetic Stimulation

Sham Comparator: Sham iTBS
Sham iTBS will be delivered using the 50Hz, 600 pulses protocol for 10 sessions over a period of two weeks. Intensity will be set at 80% RMT. Circular coil will be held over vertex of skull but angled away to ensure no neural stimulation.
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.
Other Name: repetitive Transcranial Magnetic Stimulation




Primary Outcome Measures :
  1. Feasibility Criteria 1: Number of participants recruited [ Time Frame: Through to study completion, up to 6 months ]
    Recruitment of 20 participants within 6 months (i.e. 3 - 4 participants per month)

  2. Feasibility Criteria 2: Number of participants completing intervention protocol [ Time Frame: Through to study completion, up to 6 months ]
    10 participants completing full intervention protocol

  3. Feasibility Criteria 3: Number of Valid data sets [ Time Frame: Through to study completion, up to 6 months ]
    10 complete valid data sets

  4. Feasibility Criteria 4: Number of Serious Adverse Events Experienced by Participants [ Time Frame: Through to study completion, up to 6 months ]
    No serious adverse events


Secondary Outcome Measures :
  1. Modified Ashworth Scale (MAS) [ Time Frame: Baseline and 2 weeks ]
    MAS is a clinical assessment of spasticity. Spasticity of wrist extensors, flexors, elbow extensors and flexors of both upper limbs will be assessed.

  2. Range of Motion (RoM) [ Time Frame: Baseline and 2 weeks ]
    Active RoM of wrist extension, flexion, elbow extension and flexion of both of both upper limbs will be measured using a goniometer.

  3. Leeds Arm Spasticity Impact Scale (LASIS) [ Time Frame: Baseline and 2 weeks ]
    Questionnaire assessing impact of spasticity on a person.

  4. Visual Analogue Scale (Spasticity) (VAS-S) [ Time Frame: Baseline and 2 weeks ]
    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.

  5. American Spinal Injuries Association Impairment Scale (AIS) (Inc. grading, upper extremity motor score, lower extremity motor score, light touch and pin prick scores) [ Time Frame: Baseline and 2 weeks ]
    A clinical assessment of sensory dermatomes and key muscle groups of upper and lower limbs.

  6. Spinal Cord Independence Measure (SCIM) - Version 3 [ Time Frame: Baseline and 2 weeks ]
    scale developed to address the ability of SCI patients to perform basic activities of daily living independently.

  7. Visual Analogue Scale (Pain) - (VAS-P) [ Time Frame: Baseline and 2 weeks ]
    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.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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): NCT02914418


Locations
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United Kingdom
Princess Royal Spinal Injuries Centre, Northern General Hospital.
Sheffield, South Yourkshire, United Kingdom, S5 7AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
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Study Chair: Ram Hariharan, MD Sheffield Teaching Hospital NHS Foundation Trust
Principal Investigator: Ali Gharooni Sheffield Teaching Hospital NHS Foundation Trust. University of Sheffield.

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Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02914418     History of Changes
Other Study ID Numbers: STH18997
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: May 5, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sheffield Teaching Hospitals NHS Foundation Trust:
transcranial magnetic stimulation
Spinal Cord Injuries
Muscle Spasticity
Pain
Spinal Cord
Spinal Cord Diseases

Additional relevant MeSH terms:
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Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System