Spinal Cord InjuriesREPAIR-SCINCT06065384
Neural Plasticity and Motor Recovery After Upper Extremity Motor Training in People With c-SCI
A study testing experimental group: intensive motor training in people with Spinal Cord Injuries, run by Annemie Spooren at 4 sites in 2 countries.
Trial summary
After spinal cord injury (SCI), there is a disruption in neural circuits resulting in paralysis. There is not yet a cure for paralysis. In persons with Cervical SCI (pwC-SCI) recovery of arm-hand function is very important as it has a significant impact on the patients' level of independence and quality of life. Read more about this study
- Who is it for?
- Ages 16 to 90 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- experimental group: intensive motor training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 9 Oct 2024to 28 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Traumatic or non-traumatic C-SCI in the preceding 13 weeks; age over 16 years; have an incomplete SCI categorized as AIS C or D or an AIS A SCI with zones of partial motor paralysis (as defined by the International Standards for the Neurological Classification of SCI (ISNCI) and medically stable.
Who cannot join
- SCI with ASIA Impairment Scale (AIS) A without zones of partial preservation (decided based on former studies) and expertise of the team; SCI with any significant medical condition that could prevent the person from participating. Patients will be excluded from the measures of central plasticity in the presence of contraindications for TMS application such as epilepsy, metal implants in the brain, defibrillator, pacemaker, and pregnancy
Trial locations and contacts
4 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Lisa Tedesco Triccas, Prof. Dr. contact
4 sites in 2 countries
Belgium3 sites, 3 recruiting
- Recruiting
Revalidatieziekenhuis RevArte
Antwerp, 2650
Nathalie Vaes, +32 3 210 60 95, nathalie.vaes@revarte.be
- Recruiting
UZGent
Ghent
Kristine Oostra, Prof. Dr.
- Not yet recruiting
UZLeuven Campus Pellenberg
Leuven
Koen Peers, Prof. Dr.
Netherlands1 site, 1 recruiting
- Recruiting
Zorggroep Adelante
Hoensbroek
Charlotte Van Laake, dr.
About this study
Official title: Central and Peripheral Neuroplasticity in Cervical Spinal Cord Injury Following Intensive Upper Limb Motor Training
After spinal cord injury (SCI), there is a disruption in neural circuits resulting in paralysis. There is not yet a cure for paralysis. In persons with Cervical SCI (pwC-SCI) recovery of arm-hand function is very important as it has a significant impact on the patients' level of independence and quality of life. Recovery is assumed to involve alterations in both central and peripheral motor systems. Motor training at an intensive dosage potentially provides a powerful stimulus for neurological recovery. This project exploits the peripheral and central neuroplastic effect of an early (<13 weeks after injury) and intensive (8 weeks of 6 hours in addition to usual care) upper limb motor training program (EIUMT) directed at recovery below the level of the injury in pwC-SCI within an international multi-center randomized controlled trial including 44 pwC-SCI. It has 4 objectives: to investigate 1)central neural plasticity by identifying alterations in cortical neuroplasticity and corticospinal excitability; 2)peripheral neural plasticity by identifying alterations in axonal excitability and number of motor units; 3)behavioral motor recovery of upper limb and 4)relationships between dose dimensions of motor intervention and behavioral and neurophysiological outcome measures after EIUMT. Cutting-edge neurophysiological measures are used to provide insight in the mechanism of neuroplasticity after EIUMT and will be taken before and after EIUMT and at 6 months follow-up.
Read the detailed description
Background of the study:
Paralysis or paralysis is the most common effect of spinal cord injury (SCI) on individuals. Paralysis affects the ability to walk, perform self-care, live independently and participate in work and leisure activities. In individuals with cervical spinal cord injury, arm and hand function is very important. The most promising and easily implemented intervention that could promote neurological recovery and make a lasting difference in the lives of people with spinal cord injuries is early and intensive motor training aimed at recovery below the injury level. This intervention takes advantage of the early plasticity of the nervous system. By maximizing muscle activation in the first few weeks after injury, we can target the nervous system's unique capacity for neural plasticity where changes can occur in central and peripheral motor systems.
Objective of the study:
This project aims to investigate peripheral and central neuroplasticity following an early (<13 weeks after injury) and intensive (8 weeks of 6 hours of additional therapy) upper extremity motor training program (EIUMT) aimed at recovery below the lesion level. This project has 4 objectives: to investigate 1) central neural plasticity (identify changes in cortical neuroplasticity and corticospinal excitability; 2) peripheral neural plasticity (identify change in axonal excitability and number of motor units); 3) clinical motor recovery of the upper limbs and 4) relationships between dose dimensions of motor intervention and clinical and neurophysiological outcome measures after EIUMT. Advanced neurophysiological measurements and clinical measurements will be taken before and after EIUMT and at 6-month follow-up.
Study design:
a multicenter pragmatic randomised controlled study in 2 countries
Study population:
44 persons with cervical spinal cord injury (22 participants in the control and intervention groups) Inclusion criteria: Individuals are eligible to participate if they have suffered a traumatic or non-traumatic cervical spinal cord injury within the previous 13 weeks, have AIS (ASIA Impairment Scale) A lesion with motor function more than three levels below motor level (on one or both sides) or have AIS C or AIS D lesion (as defined by the International Standards for the Neurological Classification of spinal cord injury), are older than 16 years of age, have received permission to begin rehabilitation and are likely to remain an inpatient for the next 8 weeks.
Exclusion criteria: Participants will be excluded if they have a significant medical or physical condition or psychiatric illness that could prevent the person from participating in the study or would place the person at unacceptable risk if they were to participate.
Intervention:
The intervention group receives 6 hours of motor training each week. This involves active and targeted motor training of all affected muscles below the injury level in the context of functional activities.
The control group receives only standard rehabilitation and care.
Primary study parameters/outcome of the study (Baseline vs 8 weeks after randomisation):
Central plasticity via: Single pulse TMS (transcranial magnetic stimulation) (Resting Motor Threshold) Peripheral plasticity via: Peripheral nerve assessment (Compound muscle action potential (CMAP)) Functional recovery via: Grades redefined assessment of strength, sensibility and Prehension (GRASSP)
Secondary study parameters/outcome of the study:
Clinical Measures: Upper Extremity Motor Score, Spinal Cord Independence Measure (SClM-selfcare); Van Lieshout Test (VLT); Hand-Held Dynamometry; accelerometry (session density: active therapy time/session length); perceived difficulty and exertion) Central plasticity: Single Pulse TMS: Stimulus-Response Function, Cortical mapping, Paired pulse TMS: SICI (short interval intracortical inhibition); LICI (long interval intracortical inhibition) Peripheral plasticity: NET (Nerve excitability testing) and MScanFit MUNE.
- Conditions
- Spinal Cord Injuries
- Being tested
- experimental group: intensive motor training, usual care
- Keywords
- spinal cord rehabilitation, therapy dose, neural plasticity, motor recovery, upper limb training
- 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.
experimental group: intensive motor trainingOther
Intervention group: receive an extra 6 hours of motor training each week (distributed over the week) for 8 weeks. It will involve active and targeted motor training of all affected muscles of the upper limb below the level of the injury within the context of practice of functional activities. Interventions will be goal directed and individualized to the needs of each participant with a focus on training that addresses each person's specific motor problem, promoting motor learning as well as stimulating neural plasticity. All patients will continue to receive usual physiotherapy and usual rehabilitation.
usual careOther
usual rehabilitation
| Study group | Role | What they receive |
|---|---|---|
| intensive upper limb training | Experimental | The intervention group receives 6 hours of motor training each week upon usual care during 8 weeks. This involves active and targeted motor training of all affected muscles below the injury level in the context of functional activities. Receives: Other: experimental group: intensive motor training |
| usual care | Other | The control group receives only standard rehabilitation and care Receives: Other: usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in single pulse TMS: resting motor threshold
to asses changes in cortical reactivity
Measured: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
Changes in Compound Muscle Action Potential (CMAP)
Changes in amplitude of CMAP
Measured: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
changes in GRASSP
Grades redefined assessment of strength sensibility and Prehension
Measured: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
Secondary outcomes (11)
Single-pulse TMS: Stimulus Response Curve
- to assess cortical excitability
Measured: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
changes SICI
to evaluatie changes in Short interval intracortical inhibition
Measured: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
changes in LICI
long-interval intracortical inhibition
Measured: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
changes in MscanFit MUNE
Compound muscle action potential (CMAP) scans will be recorded
Measured: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
changes in single pulse TMS: mapping
to evaluate changes in cortical reorganisation
Measured: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
changes in NET (Nerve excitability testing)
Stimulus-Response Curve, Strength duration time constant (SDTC), threshold electrotonus (TE), I/V relationship (I/V) and recovery cycles (RC) will be measured.
Measured: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
changes in behavioral measures: Upper extremity motor score
score on 50
Measured: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
changes in Spinal Cord independence Measures
questionaire: self-care score
Measured: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
changes in Van Lieshout Test
basis upper extremity skills
Measured: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
changes in hand held dynamometry
strength in hand
Measured: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
Goal satisfaction
Subjective scoring 0-10 of four goals
Measured: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2023
- Study start9 Oct 2024
- Primary completion28 Mar 2027 (estimated)
- Study completion28 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Annemie Spooren
- Sponsor type
- University, hospital or other
- Collaborators
- Research Foundation Flanders, University of Aarhus, University of Sydney, University Hospital, Ghent, Universitaire Ziekenhuizen KU Leuven, Adelante, Centre of Expertise in Rehabilitation and Audiology, Rehabilitation Hospital RevArte
- Responsible party
- Sponsor-investigator, Annemie Spooren, Hasselt University
- Investigators
- Annemie Spooren, Prof. Dr., Principal investigator, Hasselt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06065384
- Sponsor's protocol ID
- REPAIR-SCI_UH
- Acronym
- REPAIR-SCI
- Status last verified
- Dec 2025
- First submitted
- 14 Jun 2023
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudomised data will be discussed with Aarhus University because they will assist in data analyses. The protocol will be shared with the partners (Aarhus University, Sydney University, UZ Gent, UZ Leuven, RZ RevArte, and Adelante Zorggroep)
Publications
Hrycyk IJ, Bertels N, Tankisi H, Glinsky JV, Oostra K, van Laake-Geelen C, Tedesco Triccas L, Spooren A. Central and peripheral neuroplasticity in cervical spinal cord injury following intensive upper limb motor training: a randomised controlled trial protocol. BMJ Open. 2026 Mar 18;16(3):e107352. doi: 10.1136/bmjopen-2025-107352.
PubMed 41857841
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Central and Peripheral Neuroplasticity in Cervical Spinal Cord Injury Following Intensive Upper Limb Motor Training
- ClinicalTrials.gov ID
- NCT06065384
- Acronym / sponsor ID
- REPAIR-SCI / REPAIR-SCI_UH
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord rehabilitation, therapy dose, neural plasticity, motor recovery, upper limb training
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Annemie SpoorenUniversity, hospital or other
- Collaborators
- Research Foundation Flanders, University of Aarhus, University of Sydney, University Hospital, Ghent, Universitaire Ziekenhuizen KU Leuven, Adelante, Centre of Expertise in Rehabilitation and Audiology, Rehabilitation Hospital RevArte
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 28 Mar 2027 (estimated)
- Study completion
- 28 Aug 2027 (estimated)
- First posted
- 3 Oct 2023 (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.
After spinal cord injury (SCI), there is a disruption in neural circuits resulting in paralysis. There is not yet a cure for paralysis. In persons with Cervical SCI (pwC-SCI) recovery of arm-hand function is very important as it has a significant impact on the patients' level of independence and quality of life. Recovery is assumed to involve alterations in both central and peripheral motor systems. Motor training at an intensive dosage potentially provides a powerful stimulus for neurological recovery. This project exploits the peripheral and central neuroplastic effect of an early (<13 weeks after injury) and intensive (8 weeks of 6 hours in addition to usual care) upper limb motor training program (EIUMT) directed at recovery below the level of the injury in pwC-SCI within an international multi-center randomized controlled trial including 44 pwC-SCI. It has 4 objectives: to investigate 1)central neural plasticity by identifying alterations in cortical neuroplasticity and corticospinal excitability; 2)peripheral neural plasticity by identifying alterations in axonal excitability and number of motor units; 3)behavioral motor recovery of upper limb and 4)relationships between dose dimensions of motor intervention and behavioral and neurophysiological outcome measures after EIUMT. Cutting-edge neurophysiological measures are used to provide insight in the mechanism of neuroplasticity after EIUMT and will be taken before and after EIUMT and at 6 months follow-up.
Detailed description
Background of the study:
Paralysis or paralysis is the most common effect of spinal cord injury (SCI) on individuals. Paralysis affects the ability to walk, perform self-care, live independently and participate in work and leisure activities. In individuals with cervical spinal cord injury, arm and hand function is very important. The most promising and easily implemented intervention that could promote neurological recovery and make a lasting difference in the lives of people with spinal cord injuries is early and intensive motor training aimed at recovery below the injury level. This intervention takes advantage of the early plasticity of the nervous system. By maximizing muscle activation in the first few weeks after injury, we can target the nervous system's unique capacity for neural plasticity where changes can occur in central and peripheral motor systems.
Objective of the study:
This project aims to investigate peripheral and central neuroplasticity following an early (<13 weeks after injury) and intensive (8 weeks of 6 hours of additional therapy) upper extremity motor training program (EIUMT) aimed at recovery below the lesion level. This project has 4 objectives: to investigate 1) central neural plasticity (identify changes in cortical neuroplasticity and corticospinal excitability; 2) peripheral neural plasticity (identify change in axonal excitability and number of motor units); 3) clinical motor recovery of the upper limbs and 4) relationships between dose dimensions of motor intervention and clinical and neurophysiological outcome measures after EIUMT. Advanced neurophysiological measurements and clinical measurements will be taken before and after EIUMT and at 6-month follow-up.
Study design:
a multicenter pragmatic randomised controlled study in 2 countries
Study population:
44 persons with cervical spinal cord injury (22 participants in the control and intervention groups) Inclusion criteria: Individuals are eligible to participate if they have suffered a traumatic or non-traumatic cervical spinal cord injury within the previous 13 weeks, have AIS (ASIA Impairment Scale) A lesion with motor function more than three levels below motor level (on one or both sides) or have AIS C or AIS D lesion (as defined by the International Standards for the Neurological Classification of spinal cord injury), are older than 16 years of age, have received permission to begin rehabilitation and are likely to remain an inpatient for the next 8 weeks.
Exclusion criteria: Participants will be excluded if they have a significant medical or physical condition or psychiatric illness that could prevent the person from participating in the study or would place the person at unacceptable risk if they were to participate.
Intervention:
The intervention group receives 6 hours of motor training each week. This involves active and targeted motor training of all affected muscles below the injury level in the context of functional activities.
The control group receives only standard rehabilitation and care.
Primary study parameters/outcome of the study (Baseline vs 8 weeks after randomisation):
Central plasticity via: Single pulse TMS (transcranial magnetic stimulation) (Resting Motor Threshold) Peripheral plasticity via: Peripheral nerve assessment (Compound muscle action potential (CMAP)) Functional recovery via: Grades redefined assessment of strength, sensibility and Prehension (GRASSP)
Secondary study parameters/outcome of the study:
Clinical Measures: Upper Extremity Motor Score, Spinal Cord Independence Measure (SClM-selfcare); Van Lieshout Test (VLT); Hand-Held Dynamometry; accelerometry (session density: active therapy time/session length); perceived difficulty and exertion) Central plasticity: Single Pulse TMS: Stimulus-Response Function, Cortical mapping, Paired pulse TMS: SICI (short interval intracortical inhibition); LICI (long interval intracortical inhibition) Peripheral plasticity: NET (Nerve excitability testing) and MScanFit MUNE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intensive upper limb training | Experimental | Other: experimental group: intensive motor trainingThe intervention group receives 6 hours of motor training each week upon usual care during 8 weeks. This involves active and targeted motor training of all affected muscles below the injury level in the context of functional activities. |
| usual care | Other | Other: usual careThe control group receives only standard rehabilitation and care |
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Traumatic or non-traumatic C-SCI in the preceding 13 weeks; age over 16 years; have an incomplete SCI categorized as AIS C or D or an AIS A SCI with zones of partial motor paralysis (as defined by the International Standards for the Neurological Classification of SCI (ISNCI) and medically stable.
Key exclusion criteria (1 listed)
- SCI with ASIA Impairment Scale (AIS) A without zones of partial preservation (decided based on former studies) and expertise of the team; SCI with any significant medical condition that could prevent the person from participating. Patients will be excluded from the measures of central plasticity in the presence of contraindications for TMS application such as epilepsy, metal implants in the brain, defibrillator, pacemaker, and pregnancy
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 |
|---|---|---|
| experimental group: intensive motor trainingIntervention group: receive an extra 6 hours of motor training each week (distributed over the week) for 8 weeks. It will involve active and targeted motor training of all affected muscles of the upper limb below the level of the injury within the context of practice of functional activities. Interventions will be goal directed and individualized to the needs of each participant with a focus on training that addresses each person's specific motor problem, promoting motor learning as well as stimulating neural plasticity. All patients will continue to receive usual physiotherapy and usual rehabilitation. | Other | intensive upper limb training |
| usual careusual rehabilitation | Other | usual care |
Primary outcome
changes in single pulse TMS: resting motor threshold
Time frame: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
to asses changes in cortical reactivity
Changes in Compound Muscle Action Potential (CMAP)
Time frame: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
Changes in amplitude of CMAP
changes in GRASSP
Time frame: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
Grades redefined assessment of strength sensibility and Prehension
11 secondary outcomes
Single-pulse TMS: Stimulus Response Curve
Time frame: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
changes SICI
Time frame: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
changes in LICI
Time frame: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
changes in MscanFit MUNE
Time frame: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
changes in single pulse TMS: mapping
Time frame: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
changes in NET (Nerve excitability testing)
Time frame: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up
changes in behavioral measures: Upper extremity motor score
Time frame: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
changes in Spinal Cord independence Measures
Time frame: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
changes in Van Lieshout Test
Time frame: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
changes in hand held dynamometry
Time frame: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
Goal satisfaction
Time frame: - before intervention; at 8 weeks (after intervention) and at 6 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Derived from this study: PubMed 41857841Hrycyk IJ, Bertels N, Tankisi H, Glinsky JV, Oostra K, van Laake-Geelen C, Tedesco Triccas L, Spooren A. Central and peripheral neuroplasticity in cervical spinal cord injury following intensive upper limb motor training: a randomised controlled trial protocol. BMJ Open. 2026 Mar 18;16(3):e107352. doi: 10.1136/bmjopen-2025-107352.
- Individual participant dataSharing planned: Yes. Pseudomised data will be discussed with Aarhus University because they will assist in data analyses. The protocol will be shared with the partners (Aarhus University, Sydney University, UZ Gent, UZ Leuven, RZ RevArte, and Adelante Zorggroep)
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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.
Lisa Tedesco Triccas, Prof. Dr. contact
Annemie Spooren, Prof. Dr. principal investigator
Hasselt University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing experimental group: intensive motor training in people with Spinal Cord Injuries, run by Annemie Spooren at 4 sites in 2 countries.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Belgium, Netherlands. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Annemie Spooren, Prof. Dr. (11269332, annemie.spooren@uhasselt.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in single pulse TMS: resting motor threshold (time frame: - before intervention; at 4 weeks (inbetween measure), at 8 weeks (after intervention) and at 6 months follow-up). 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?
On the ClinicalTrials.gov record for NCT06065384, which also lists 1 linked publication.
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 12 Dec 2025.