Spinal Cord InjuryrTMS:NCT04372134

The Effect of rTMS in Patients With Spinal Cord Injury (rTMS:Repetetive Transcranial Magnetic Stimulation)

A study testing repetitive transcranial magnetic stimulation therapy in people with Spinal Cord Injury, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

It is postulated that high frequency repetitive transcranial magnetic stimulation (rTMS) can decrease the corticospinal inhibition and enhance the motor recovery. This study is aimed to investigate the effect of high frequency rTMS on lower extremity motor recovery and gait parameters in patients with chronic motor… Read more about this study

Who is it for?: Ages 18 to 45 years
Conditions the study is for: Spinal Cord Injury
What is being tested?: repetitive transcranial magnetic stimulation therapy
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 28 participants
Where: No sites listed yet
Study dates: 1 Oct 2015to 1 Apr 2017
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
No healthy volunteers
Adult

Who may be able to join

the diagnosis of motor incomplete cervical or thoracic spinal cord injury (ASIA C or D), spinal cord injury due to trauma at least one year previously
the ability to walk at least 10 meters independently or with assisted devices such as cane / canadian, age (18-45 years). All participants signed the informed consent form.

Who cannot join

the presence of other musculoskeletal or neurological diseases that may prevent walking, lower motor neuron lesion (cauda equina and conus medullaris)
family history of epilepsy
the presence of brain injury
the presence of cranium defect
the presence of pacemaker
pregnancy

About this study

Official title: The Effect of High Frequency Repetetive Transcranial Magnetic Stimulation on Motor Recovery and Gait Parameters in Patients With Chronic Incomplete Spinal Cord Injury

Read the detailed description

A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance. Lower extremity motor score (LEMS), the temporal-spatial gait parameters measured by 3D gait analysis, Walking Index for SCI-II (WISCI-II) scale and 10 meters walking test were assessed at baseline, 3 weeks (after the treatment sessions) and 5 weeks (follow-up).

Conditions: Spinal Cord Injury
Being tested: repetitive transcranial magnetic stimulation therapy
Keywords: r TMS, spinal cord injury, motor recovery,, gait
Medical subject headings: Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

repetitive transcranial magnetic stimulation therapyDevice
Also called rehabilitation program
A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance.

Study groups in NCT04372134
Study group	Role	What they receive
real rTMS group	Active comparator	motor incomplete traumatic SCI patients receiving real repetitive transcranial magnetic stimulation therapy Receives: Device: repetitive transcranial magnetic stimulation therapy
sham r TMS	Sham comparator	motor incomplete traumatic SCI patients receiving sham repetitive transcranial magnetic stimulation therapy Receives: Device: repetitive transcranial magnetic stimulation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

The lower extremity motor scores of the patients
The lower extremity motor scores of the patients (degree of muscle strength according to the American Spinal Injury Association (ASIA) Impairment Scale )(The assesment of ASIA scale includes 5 classification as ASIA A, B,C,D,E. ASIA A is the worst score and ASIA E is the best score)
Measured: through study completion, an average of 2 weeks (Change from Baseline The lower extremity motor scores of the patients at 2 weeks.)

Secondary outcomes (9)

the parameters of gait analysis - walking speed
walking speed (centimeter/second) obtained in the motion analysis laboratory
Measured: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
the parameters of gait analysis - cadence
cadence (number of steps/minute) obtained in the motion analysis laboratory
Measured: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
the parameters of gait analysis - single support time
single support time (second) obtained in the motion analysis laboratory
Measured: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
the parameters of gait analysis - double support time
double support time (second) obtained in the motion analysis laboratory
Measured: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
the parameters of gait analysis - contralateral foot contact time
contralateral foot contact time (second) obtained in the motion analysis laboratory
Measured: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
the parameters of gait analysis - step time
step time (second) obtained in the motion analysis laboratory
Measured: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
the parameters of gait analysis - step speed
step speed (centimeter/second)) obtained in the motion analysis laboratory
Measured: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
Walking Index for SCI - II (WISCI-II) Scale
Walking Index for SCI - II (WISCI-II) Scale (WISCI -II is a scale to assess the amount of physical assistance needed as well as device reuired for walking ( The development of this assessment index required a rank ordering along a dimension of impairment, from the level of most severe impairment (0) to least severe impairment (20) based on the use of devices, braces and physical assistance of one or more persons. The order of the levels suggests each successive level is a less impaired level than the former)
Measured: through study completion, an average of 2 weeks (Change from Baseline WISCI II scale scores of the patients at 2 weeks.)
10-meter Gait Test
10-meter Gait Test (This test is used to assess walking speed in meters per second over a short duration
Measured: through study completion, an average of 2 weeks (Change from Baseline 10 meter gait test scores of the patients at 2 weeks.)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 20151 Apr 2017

First posted1 May 2020
Study start1 Oct 2015
Primary completion1 Apr 2017
Study completion1 Apr 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Outcomes assessor
Enrolment: 28 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04372134
Sponsor's protocol ID: 3
Acronym: rTMS:
Status last verified: Apr 2020
First submitted: 8 Apr 2020
Last updated: 1 May 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of High Frequency Repetetive Transcranial Magnetic Stimulation on Motor Recovery and Gait Parameters in Patients With Chronic Incomplete Spinal Cord Injury
ClinicalTrials.gov ID: NCT04372134
Acronym / sponsor ID: rTMS: / 3
Conditions: Spinal Cord Injury
Keywords: r TMS, spinal cord injury, motor recovery,, gait
Study type: Interventional
Recruitment status: Completed
Enrolment: 28 participants (actual)
Lead sponsor: Gaziler Physical Medicine and Rehabilitation Education and Research HospitalUniversity, hospital or other
Study start: 1 Oct 2015 (actual)
Primary completion: 1 Apr 2017 (actual)
Study completion: 1 Apr 2017 (actual)
First posted: 1 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
real rTMS group	Active comparator	Device: repetitive transcranial magnetic stimulation therapymotor incomplete traumatic SCI patients receiving real repetitive transcranial magnetic stimulation therapy
sham r TMS	Sham comparator	Device: repetitive transcranial magnetic stimulation therapymotor incomplete traumatic SCI patients receiving sham repetitive transcranial magnetic stimulation therapy

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

the diagnosis of motor incomplete cervical or thoracic spinal cord injury (ASIA C or D), spinal cord injury due to trauma at least one year previously
the ability to walk at least 10 meters independently or with assisted devices such as cane / canadian, age (18-45 years). All participants signed the informed consent form.

Key exclusion criteria (6 listed)

the presence of other musculoskeletal or neurological diseases that may prevent walking, lower motor neuron lesion (cauda equina and conus medullaris)
family history of epilepsy
the presence of brain injury
the presence of cranium defect
the presence of pacemaker

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
repetitive transcranial magnetic stimulation therapyAlso: rehabilitation programA sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance.	Device	real rTMS group, sham r TMS

Primary outcome

The lower extremity motor scores of the patients
Time frame: through study completion, an average of 2 weeks (Change from Baseline The lower extremity motor scores of the patients at 2 weeks.)
The lower extremity motor scores of the patients (degree of muscle strength according to the American Spinal Injury Association (ASIA) Impairment Scale )(The assesment of ASIA scale includes 5 classification as ASIA A, B,C,D,E. ASIA A is the worst score and ASIA E is the best score)

9 secondary outcomes

the parameters of gait analysis - walking speed
Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
the parameters of gait analysis - cadence
Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
the parameters of gait analysis - single support time
Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
the parameters of gait analysis - double support time
Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
the parameters of gait analysis - contralateral foot contact time
Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
the parameters of gait analysis - step time
Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
the parameters of gait analysis - step speed
Time frame: through study completion, an average of 2 weeks (Change from Baseline parameters of gait analysis of the patients at 2 weeks.)
Walking Index for SCI - II (WISCI-II) Scale
Time frame: through study completion, an average of 2 weeks (Change from Baseline WISCI II scale scores of the patients at 2 weeks.)
10-meter Gait Test
Time frame: through study completion, an average of 2 weeks (Change from Baseline 10 meter gait test scores of the patients at 2 weeks.)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2020.
Individual participant dataSharing planned: No

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Recruiting
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Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

SERDAR KESİKBURUN, MD study director

The Scientific and Technological Research Council of Turkey

AYÇA URAN ŞAN principal investigator

The Scientific and Technological Research Council of Turkey

Questions about this trial

What is this clinical trial studying?

A study testing repetitive transcranial magnetic stimulation therapy in people with Spinal Cord Injury, run by Gaziler Physical Medicine and Rehabilitation Education and Research Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The lower extremity motor scores of the patients (time frame: through study completion, an average of 2 weeks (Change from Baseline The lower extremity motor scores of the patients at 2 weeks.)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04372134.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2020.