Chronic Spinal Cord DisorderNCT06188130
The Effects of rTMS and tDCS Combined With Robotic Rehabilitation In Patients With Spinal Cord Injury
A study testing active rTMS and active tDCS in people with Chronic Spinal Cord Disorder, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to assess the effect of rTMS and tDCS combined with robotic therapy on motor functional recovery and gait parameters Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Spinal Cord Disorder
- What is being tested?
- active rTMS and active tDCS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2021to 15 Jan 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having traumatic SCI
- Between 6 months and 2 years after SCI
- 18-65 years old
- Signing an informed consent form showing his/her consent to participate in the study.
- Motor incomplete cervical or thoracic SCI
- Spasticity in the lower extremity ≤2 according to the Modified Ashworth Scale
Who cannot join
- History of epilepsy
- A cardiac pacemaker
- Pregnancy
- Neurological diseases other than SCI
- Metallic implant in brain or scalp (including cochlear implant)
- Previous brain surgery
Show all 9Show fewer
- Orthopedic disease that prevents lower extremity movements
- Diagnosis of malignancy
- Receiving robotic /TMS/tDCS treatments in the last 6 months
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital Pyhsical Treatment and Rehabilitation Hospital
Ankara
About this study
Official title: The Effect of rTMS and tDCS Treatments Combined With Robotic Rehabilitation on Gait and Motor Recovery in Partial Chronic Spinal Cord Injury
The purpose of this study is to assess the effect of rTMS and tDCS combined with robotic therapy on motor functional recovery and gait parameters
Read the detailed description
After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility requirements will be randomized into four groups in a 1:1 ratio to active rTMS, sham rTMS, active tDCS and sham tDCS.
- Conditions
- Chronic Spinal Cord Disorder
- Being tested
- active rTMS, sham rTMS, active tDCS, sham tDCS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMSOther
Participants recevied 20 Hz high frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. Motor threshold was defined as the minimum stimulus intensity eliciting 5 responses of about 50 µV out of 10 consecutive trials (50% successful MEPS) in the relaxed dominant side abductor pollicis brevis (APB).The patient received robotic therapy for lower extremity just after each active TMS sessions.
sham rTMSOther
Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil employed was identical in shape and size to the real stimulation coil and produced no magnetic field. The patient received robotic therapy for lower extremity just after each sham TMS sessions.
active tDCSOther
Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions.The electrodes will be placed anodal to the Cz central (International 10/20 Electroencephalogram System) area, corresponding to the location of the dominant hemisphere lower extremity motor cortex and cathodal to the contralateral supraorbital region. The patient received robotic therapy for lower extremity just after each active tDCS sessions.
sham tDCSOther
Participants recevied sham stimulation were applied current was ramped up either over 10 seconds, with an equal amount of time for tapering off. The patient received robotic therapy for lower extremity just after each sham tDCS sessions
| Study group | Role | What they receive |
|---|---|---|
| active rTMS | Experimental | Participants recevied 20 Hz high frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. The patient received robotic therapy for lower extremity just after each active TMS sessions Receives: Other: active rTMS |
| sham rTMS | Sham comparator | Participants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil. The patient received robotic therapy for lower extremity just after each sham TMS sessions Receives: Other: sham rTMS |
| active tDCS | Experimental | Participants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions. The patient received robotic therapy for lower extremity just after each active tDCS sessions Receives: Other: active tDCS |
| sham tDCS | Sham comparator | Participants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions Receives: Other: sham tDCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower extremity motor scores according to ASIA examination
ASIA (American Spinal Injury Association) Classification System is used to assess and determine the neurological status of individuals with spinal cord injuries. This classification system consists of five different classes:
ASIA A:There is complete loss of motor and sensory function. ASIA B:Sensation is present in the sacral region (S4-S5), but motor function loss persists.
ASIA C:Motor function loss persists, but there is observable muscle contraction (muscle strength) in specific muscle groups.
ASIA D:Motor function loss continues, but uncontrolled movements can be observed.
ASIA E:Normal sensory and motor functions are present.
The ASIA classification is a widely used system for evaluating the severity and effects of spinal cord injuries. This classification provides important guidance for the planning of treatment and rehabilitation processes.
Measured: initial, 3th week 9th week changes
Walking Index for SCI - II (WISCI-II)
Physical limitation for walking secondary to impairment is defined at the person level and indicates the ability of a person to walk after spinal cord injury. 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. The ranking of severity is based on the severity of the impairment and not on functional independence in the environment.
Measured: initial, 3th week 9th week changes
10 meter walking test
The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance[1]. It can be employed to determine functional mobility and gait.
Measured: initial, 3th week 9th week changes
Secondary outcomes (2)
Modified Ashworth Scale
İts performed by extending the patients limb first from a position of maximal possible flexion to maximal possible extension ( the point at which the first soft resistance is met). Afterwards, the modified Ashworth scale is assessed while moving from extension to flexion
0 No increase in tone
1 slight increase in tone giving a catch when slight increase in muscle tone, manifested by the limb was moved in flexion or extension.
1+ slight increase in muscle tone, manifested by a catch followed by minimal resistance throughout (ROM ) 2 more marked increase in tone but more marked increased in muscle tone through most limb easily flexed 3 considerable increase in tone, passive movement difficult 4 limb rigid in flexion or extension
Measured: initial, 3th week 9th week changes
Visual Analogue Scale
The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 (no pain) and 10 (pain as bad as it could possibly be).
Measured: initial, 3th week 9th week changes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2024
- Study start15 Jan 2021
- Primary completion30 Dec 2023 (estimated)
- Study completion15 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Spinal Cord DisorderStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emre Adıgüzel, Ankara City Hospital Bilkent
- Investigators
- Emre Adıgüzel, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06188130
- Sponsor's protocol ID
- 10025144
- Status last verified
- Aug 2023
- First submitted
- 24 Aug 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of rTMS and tDCS Treatments Combined With Robotic Rehabilitation on Gait and Motor Recovery in Partial Chronic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT06188130
- Acronym / sponsor ID
- 10025144
- Conditions
- Chronic Spinal Cord Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 15 Jan 2024 (estimated)
- First posted
- 3 Jan 2024 (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.
The purpose of this study is to assess the effect of rTMS and tDCS combined with robotic therapy on motor functional recovery and gait parameters
Detailed description
After being informed about study and potential risks, all patient giving written informed consent will undergo screening period determine eligibility for study entry. The patients who meet the eligibility requirements will be randomized into four groups in a 1:1 ratio to active rTMS, sham rTMS, active tDCS and sham tDCS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| active rTMS | Experimental | Other: active rTMSParticipants recevied 20 Hz high frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. The patient received robotic therapy for lower extremity just after each active TMS sessions |
| sham rTMS | Sham comparator | Other: sham rTMSParticipants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil. The patient received robotic therapy for lower extremity just after each sham TMS sessions |
| active tDCS | Experimental | Other: active tDCSParticipants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions. The patient received robotic therapy for lower extremity just after each active tDCS sessions |
| sham tDCS | Sham comparator | Other: sham tDCSParticipants recevied sham stimulation. The patient received robotic therapy for upper extremity just after each sham tDCS sessions |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having traumatic SCI
- Between 6 months and 2 years after SCI
- 18-65 years old
- Signing an informed consent form showing his/her consent to participate in the study.
- Motor incomplete cervical or thoracic SCI
Key exclusion criteria (9 listed)
- History of epilepsy
- A cardiac pacemaker
- Pregnancy
- Neurological diseases other than SCI
- Metallic implant in brain or scalp (including cochlear implant)
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 |
|---|---|---|
| active rTMSParticipants recevied 20 Hz high frequency repetetive TMS during 20 minutes and a total of 1200 stimuli for 15 sessions. Motor threshold was defined as the minimum stimulus intensity eliciting 5 responses of about 50 µV out of 10 consecutive trials (50% successful MEPS) in the relaxed dominant side abductor pollicis brevis (APB).The patient received robotic therapy for lower extremity just after each active TMS sessions. | Other | active rTMS |
| sham rTMSParticipants recevied sham TMS during 20 minutes and a total of 1200 sham stimuli for 15 sessions with sham coil employed was identical in shape and size to the real stimulation coil and produced no magnetic field. The patient received robotic therapy for lower extremity just after each sham TMS sessions. | Other | sham rTMS |
| active tDCSParticipants recevied 2 mA anodal transcranial direct current stimulation 20 minutes for 15 sessions.The electrodes will be placed anodal to the Cz central (International 10/20 Electroencephalogram System) area, corresponding to the location of the dominant hemisphere lower extremity motor cortex and cathodal to the contralateral supraorbital region. The patient received robotic therapy for lower extremity just after each active tDCS sessions. | Other | active tDCS |
| sham tDCSParticipants recevied sham stimulation were applied current was ramped up either over 10 seconds, with an equal amount of time for tapering off. The patient received robotic therapy for lower extremity just after each sham tDCS sessions | Other | sham tDCS |
Primary outcome
Lower extremity motor scores according to ASIA examination
Time frame: initial, 3th week 9th week changes
ASIA (American Spinal Injury Association) Classification System is used to assess and determine the neurological status of individuals with spinal cord injuries. This classification system consists of five different classes: ASIA A:There is complete loss of motor and sensory function. ASIA B:Sensation is present in the sacral region (S4-S5), but motor function loss persists. ASIA C:Motor function loss persists, but there is observable muscle contraction (muscle strength) in specific muscle groups. ASIA D:Motor function loss continues, but uncontrolled movements can be observed. ASIA E:Normal sensory and motor functions are present. The ASIA classification is a widely used system for evaluating the severity and effects of spinal cord injuries. This classification provides important guidance for the planning of treatment and rehabilitation processes.
Walking Index for SCI - II (WISCI-II)
Time frame: initial, 3th week 9th week changes
Physical limitation for walking secondary to impairment is defined at the person level and indicates the ability of a person to walk after spinal cord injury. 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. The ranking of severity is based on the severity of the impairment and not on functional independence in the environment.
10 meter walking test
Time frame: initial, 3th week 9th week changes
The 10 Metre Walk Test is a performance measure used to assess walking speed in meters per second over a short distance[1]. It can be employed to determine functional mobility and gait.
2 secondary outcomes
Modified Ashworth Scale
Time frame: initial, 3th week 9th week changes
Visual Analogue Scale
Time frame: initial, 3th week 9th week changes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Emre Adıgüzel principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active rTMS and active tDCS in people with Chronic Spinal Cord Disorder, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Lower extremity motor scores according to ASIA examination (time frame: initial, 3th week 9th week changes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2024.