Multiple SclerosisNEXIMSNCT06374108
Resistance Training and Corticospinal Excitability in Multiple Sclerosis
A study testing Progressive resistance training in people with Multiple Sclerosis, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The goal of the present study is to investigate effects of progressive resistance training on central nervous system functioning (corticospinal excitability (CSE)) and walking capacity in persons with multiple sclerosis (pwMS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Progressive resistance training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 May 2024to 31 May 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- MS diagnosis according to the McDonald diagnostic criteria
- Shows impairments in walking capacity
- Ability to self transport to test and exercise
Who cannot join
- Pregnancy
- Neurological or other comorbidities that affects the nervous system
- Relapse within the past 2 months
- Pacemaker or metallic implants
- Hypertension (medically unregulated)
- Participation in structured RT over the past 3 months (≥ 2 sessions/week).
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Recruiting
Department of Public Health
Aarhus, Central Jutland, 8000
Annette Bachmann, +4587167986, ab@ph.au.dk
- Recruiting
Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, Copenhagen N, 2200
Kristian Levring Madsen, +45 3532 0829, nexs@nexs.ku.dk
About this study
Official title: Effects of Supervised Progressive Resistance Training on Central Nervous System Functioning (Corticospinal Excitability) and Walking Capacity in Persons With Multiple Sclerosis
The goal of the present study is to investigate effects of progressive resistance training on central nervous system functioning (corticospinal excitability (CSE)) and walking capacity in persons with multiple sclerosis (pwMS). A total of 54 pwMS will be enrolled and randomized into 1 of 3 groups: high dose resistant training (RT), low dose RT, and waitlist control.
Read the detailed description
Neurodegeneration is a hallmark of multiple sclerosis (MS), affecting both structure and function of the central nervous system (CNS). Neurodegeneration is the main driver of disability progression in MS, evidenced by studies showing deleterious structural and functional CNS changes, ultimately reducing quality of life. Consequently, the interaction between the nervous system and muscular system undergoes deleterious changes causing reduced neuromuscular function (i.e., ability to develop muscle strength and power) and physical function.
The functional CNS changes have been evidenced by using the non invasive brain stimulation technique Transcranial Magnetic Stimulation, showing decreased corticospinal excitability alongside increased central motor conduction time. Moreover, functional peripheral nervous system (PNS) changes have been evidenced by nerve conduction methods, revealing decreased amplitude of compound muscle action potential and increased latency of nerve signaling. In an ongoing exploratory study (unpublished), the investigators have observed that functional CNS and PNS outcomes deteriorate with disability progression from healthy to mildly to moderately disabled people with MS (PwMS).
Exercise is beneficial from both an individual and a societal perspective, and has proven to be both safe and without any noticeable side effects in PwMS. Resistance training (RT) appears particularly effective in improving neuromuscular function (mainly muscle strength) and physical function (especially walking capacity). Whilst RT and other exercise modalities may elicit positive effects on CNS structure in PwMS, it seems to require a long-term (≥ 6 months) exposure. In contrast, CNS (and potentially PNS) function may adapt much more rapidly, despite a scarcity of studies (and with heterogeneous findings) involving PwMS. Interestingly, an exploratory exercise study (non-controlled, low sample size, 10 weeks treadmill walking intervention) assessed corticospinal excitability in PwMS, and observed substantial improvements after the intervention. Apart from this study, a major knowledge gap exists in terms of elucidating the potential beneficial effects of exercise (RT in particular) on CNS (and PNS) function. Based on evidence from healthy young individuals, substantial improvements in corticospinal excitability have been shown following 2-12 weeks of RT, supporting that RT-induced improvements in corticospinal excitability can also be seen in PwMS. Lastly, as existing exercise guidelines for PwMS fails to refer to evidence on dose-response to exercise, and a recent systematic review on exercise studies found no dose-response studies in PwMS (n=202), this aspect is also of great clinical relevance.
- Conditions
- Multiple Sclerosis
- Being tested
- Progressive resistance training
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive resistance trainingBehavioural
The RT exercise regime will focus on lower extremity exercises (60-90% of 1 repetition maximum) as well as incorporating functional exercises.
| Study group | Role | What they receive |
|---|---|---|
| High dose resistance training | Active comparator | 10 weeks intervention with 2.5 weekly supervised resistance training sessions (2 or 3 sessions/week for high dose resistance training; 25 sessions in total). Receives: Behavioral: Progressive resistance training |
| Low dose resistance training | Active comparator | 10 weeks intervention with 1 weekly supervised resistance training session (low dose resistance training; 10 sessions in total). Receives: Behavioral: Progressive resistance training |
| Waitlist control. | No intervention | The waitlist control group will initially be instructed to maintain their normal daily activity during the 10 week intervention period. Hereafter, they will be offered a 10 week high dose resistance training intervention that combines supervised and home based exercise sessions . |
What is being measured
The primary outcome is the main question the study is designed to answer.
MEP/Mmax ratio
Cortical excitability measured as amplitude percentage ratio between MEP (resting) and Mmax (Cmap of TA). Unit (intended): %
Measured: Change from Baseline to 10 weeks
Secondary outcomes (31)
Muscle strength
Maximal voluntary contraction (MVC) is the maximal force-generating capacity (plantar flexion and dorsal flexion). Unit (intended): N
Measured: Change from Baseline to 10 weeks
Voluntary activation I
Assessed by Interpolated Twitch Technique (ITT) (dorsal flexion). Unit (intended): %
Measured: Change from Baseline to 10 weeks
Voluntary activation II
EMG amplitude during MVC (plantar flexion and dorsal flexion). Unit (intended): μV
Measured: Change from Baseline to 10 weeks
Force Steadiness
A quantitative measure of the ability to control muscle tonus (dorsal flexion). Unit (intended): root-mean-square (RMS) error (Coefficient of Variation (CV))
Measured: Change from Baseline to 10 weeks
Rate of Force Developement
This is defined as the speed at which the contractile elements of the muscle can develop force (plantar flexion and dorsal flexion). Unit (intended): N/s
Measured: Change from Baseline to 10 weeks
Ultrasound
Measure of muscle thickness of the tibialis anterior. Unit (intended): mm
Measured: Change from Baseline to 10 weeks
Resting Motor Threshold (rMT)
The intensity necessary to produce a motor-evoked potential (MEP) that exceeds a defined peak-to-peak amplitude (50 μV) 50% of the time in a finite number of trials. Unit (intended): % Maximum stimulator output (MSO)
Measured: Change from Baseline to 10 weeks
Active Motor Threshold (aMT)
The intensity necessary to produce a motor-evoked potential (MEP) that exceeds a defined peak-to-peak amplitude (50 μV) 50% of the time in a finite number of trials during voluntary activation (20% of MVC). Unit (intended): % Maximum stimulator output (MSO)
Measured: Change from Baseline to 10 weeks
MEP latency (resting)
The transmission time from stimulating the cortex to the start of the evoked potential in the EMG of the target muscle. Unit (intended): ms
Measured: Change from Baseline to 10 weeks
MEP latency (active)
The transmission time from stimulating the cortex to the start of the evoked potential in the EMG of the target muscle. Unit (intended): ms
Measured: Change from Baseline to 10 weeks
MEP amplitude (resting)
Peak-to-peak of averaged MEP (20 stimulations of 120% rMT). Unit (intended): mV
Measured: Change from Baseline to 10 weeks
MEP amplitude (active)
Peak-to-peak of averaged MEP (20 stimulations of 120% rMT). Unit (intended): mV
Measured: Change from Baseline to 10 weeks
Short-interval intracortical Inhibition (SICI)
SICI measures cortical inhibition and is a TMS protocol in which two stimuli are delivered with an interstimulus interval (ISI) of 2.5 ms. Unit (intended): the relative amplitude difference of motor evoked potentials (MEPs) (%).
Measured: Change from Baseline to 10 weeks
Intracortical facilitation (ICF)
ICF measures cortical facilitation and is a TMS protocol in which two stimuli are delivered with an interstimulus interval (ISI) of 10 ms. Unit (intended): the relative amplitude reduction of motor evoked potentials (MEPs) (%).
Measured: Change from Baseline to 10 weeks
Cortical Silent Period (CSP)
The temporary interruption of electromyographic signal from a muscle following a motor-evoked potential (MEP) triggered by transcranial magnetic stimulation (TMS). Unit (intended): ms
Measured: Change from Baseline to 10 weeks
Central Motor Conduction Time (CMCT)
The time it takes for the fastest action potentials to travel from the site of cortical stimulation to the spinal motoneuron. It is calculated by subtracting the peripheral motor conduction time (PMCT) from the MEP latency or by the F-wave method. Unit (intended): ms
Measured: Change from Baseline to 10 weeks
EEG-EMG coherence (0-1)
Synchronization between brain activity (EEG) and muscle activity (EMG) over a specific frequency range. Unit (intended): ranging from 0 to 1, where 0 is no coherence and 1 is perfect coherence.
Measured: Change from Baseline to 10 weeks
Timed 25 feet walk test (T25FWT)
Objective test that measures walking speed. Unit (intended): seconds.
Measured: Change from Baseline to 10 weeks
6-minute walk test (6MWT)
Objective test that measures walking endurance. Unit (intended): meters.
Measured: Change from Baseline to 10 weeks
Six spot step test (SSST)
Objective test that measures walking coordination and balance. Unit (intended): seconds.
Measured: Change from Baseline to 10 weeks
5 sit-to-stand (5STS)
Objective test that measures functional lower limb muscle strength and power. Unit (intended): seconds.
Measured: Change from Baseline to 10 weeks
9-step stair ascend (9SSA)
Objective test that measures functional lower limb muscle strength and power. Unit (intended): seconds.
Measured: Change from Baseline to 10 weeks
Patient determined disease steps (PDDS)
A patient-reported measure of disability. Unit (intended): score (0-8; 0 is normal).
Measured: Change from Baseline to 10 weeks
Multiple Sclerosis Walking Scale (MSWS)
Questionnaire that measures quality of life. Unit (intended): score (0-100; 0 is better).
Measured: Change from Baseline to 10 weeks
Modified fatigue impact scale (MFIS)
Questionnaire that measures the impact fatigue has on daily life. Unit (intended): score (0-84; 0 is better)
Measured: Change from Baseline to 10 weeks
MS impact scale (MSIS)
Questionnaire that measures the impact MS has on daily life. Unit (intended): score (29-145; 29 is better)
Measured: Change from Baseline to 10 weeks
Falls-efficacy scale - international (FES-1)
Questionnaire that measures concerns about falling. Unit (intended): score (16-64; 16 is better)
Measured: Change from Baseline to 10 weeks
The Physical Activity Enjoyment Scale (PACES)
Questionnaire that measures enjoyment for physical activity. Unit (intended): score (8-56; Higher score reflect greater level of enjoyment)
Measured: Change from Baseline to 10 weeks
Brief pain inventory (BPI)
Questionnaire that measures pain severity and pain interference. Unit (intended): No scoring algorithm, but "worst pain" or the arithmetic mean of the four severity items can be used as measures of pain severity; the arithmetic mean of the seven interference items can be used as a measure of pain interference.
Measured: Change from Baseline to 10 weeks
Baecke physical activity
Questionnaire (patient-reported outcome) assessing patient-reported participation in physical activities. Unit (intended): Score range is continuous (0-xx). Higher is better.
Measured: Change from Baseline to 10 weeks
Accelerometry
Method used to measures and analyze movement and acceleration in three dimensions of a person (physical activity). Unit (intended): g (m/s^2)
Measured: Change from Baseline to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 May 2026 (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 Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, University of Copenhagen
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374108
- Sponsor's protocol ID
- Neuro_Exercise
- Acronym
- NEXIMS
- Status last verified
- Dec 2024
- First submitted
- 16 Apr 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Andersen TM, Riis H, Tankisi H, Mamoei S, Langeskov-Christensen M, Dalgas U, Lundbye-Jensen J, Hvid LG. Effects of supervised progressive resistance training on corticospinal excitability in persons with multiple sclerosis: A randomized controlled trial protocol for the NEXIMS study. Contemp Clin Trials. 2026 Jun;165:108317. doi: 10.1016/j.cct.2026.108317. Epub 2026 Apr 15.
PubMed 41991058
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Supervised Progressive Resistance Training on Central Nervous System Functioning (Corticospinal Excitability) and Walking Capacity in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT06374108
- Acronym / sponsor ID
- NEXIMS / Neuro_Exercise
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- Aarhus University Hospital, University of Copenhagen
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 18 Apr 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 goal of the present study is to investigate effects of progressive resistance training on central nervous system functioning (corticospinal excitability (CSE)) and walking capacity in persons with multiple sclerosis (pwMS). A total of 54 pwMS will be enrolled and randomized into 1 of 3 groups: high dose resistant training (RT), low dose RT, and waitlist control.
Detailed description
Neurodegeneration is a hallmark of multiple sclerosis (MS), affecting both structure and function of the central nervous system (CNS). Neurodegeneration is the main driver of disability progression in MS, evidenced by studies showing deleterious structural and functional CNS changes, ultimately reducing quality of life. Consequently, the interaction between the nervous system and muscular system undergoes deleterious changes causing reduced neuromuscular function (i.e., ability to develop muscle strength and power) and physical function.
The functional CNS changes have been evidenced by using the non invasive brain stimulation technique Transcranial Magnetic Stimulation, showing decreased corticospinal excitability alongside increased central motor conduction time. Moreover, functional peripheral nervous system (PNS) changes have been evidenced by nerve conduction methods, revealing decreased amplitude of compound muscle action potential and increased latency of nerve signaling. In an ongoing exploratory study (unpublished), the investigators have observed that functional CNS and PNS outcomes deteriorate with disability progression from healthy to mildly to moderately disabled people with MS (PwMS).
Exercise is beneficial from both an individual and a societal perspective, and has proven to be both safe and without any noticeable side effects in PwMS. Resistance training (RT) appears particularly effective in improving neuromuscular function (mainly muscle strength) and physical function (especially walking capacity). Whilst RT and other exercise modalities may elicit positive effects on CNS structure in PwMS, it seems to require a long-term (≥ 6 months) exposure. In contrast, CNS (and potentially PNS) function may adapt much more rapidly, despite a scarcity of studies (and with heterogeneous findings) involving PwMS. Interestingly, an exploratory exercise study (non-controlled, low sample size, 10 weeks treadmill walking intervention) assessed corticospinal excitability in PwMS, and observed substantial improvements after the intervention. Apart from this study, a major knowledge gap exists in terms of elucidating the potential beneficial effects of exercise (RT in particular) on CNS (and PNS) function. Based on evidence from healthy young individuals, substantial improvements in corticospinal excitability have been shown following 2-12 weeks of RT, supporting that RT-induced improvements in corticospinal excitability can also be seen in PwMS. Lastly, as existing exercise guidelines for PwMS fails to refer to evidence on dose-response to exercise, and a recent systematic review on exercise studies found no dose-response studies in PwMS (n=202), this aspect is also of great clinical relevance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose resistance training | Active comparator | Behavioral: Progressive resistance training10 weeks intervention with 2.5 weekly supervised resistance training sessions (2 or 3 sessions/week for high dose resistance training; 25 sessions in total). |
| Low dose resistance training | Active comparator | Behavioral: Progressive resistance training10 weeks intervention with 1 weekly supervised resistance training session (low dose resistance training; 10 sessions in total). |
| Waitlist control. | No intervention | –The waitlist control group will initially be instructed to maintain their normal daily activity during the 10 week intervention period. Hereafter, they will be offered a 10 week high dose resistance training intervention that combines supervised and home based exercise sessions . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- MS diagnosis according to the McDonald diagnostic criteria
- Shows impairments in walking capacity
- Ability to self transport to test and exercise
Key exclusion criteria (6 listed)
- Pregnancy
- Neurological or other comorbidities that affects the nervous system
- Relapse within the past 2 months
- Pacemaker or metallic implants
- Hypertension (medically unregulated)
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 |
|---|---|---|
| Progressive resistance trainingThe RT exercise regime will focus on lower extremity exercises (60-90% of 1 repetition maximum) as well as incorporating functional exercises. | Behavioural | High dose resistance training, Low dose resistance training |
Primary outcome
MEP/Mmax ratio
Time frame: Change from Baseline to 10 weeks
Cortical excitability measured as amplitude percentage ratio between MEP (resting) and Mmax (Cmap of TA). Unit (intended): %
31 secondary outcomes
Muscle strength
Time frame: Change from Baseline to 10 weeks
Voluntary activation I
Time frame: Change from Baseline to 10 weeks
Voluntary activation II
Time frame: Change from Baseline to 10 weeks
Force Steadiness
Time frame: Change from Baseline to 10 weeks
Rate of Force Developement
Time frame: Change from Baseline to 10 weeks
Ultrasound
Time frame: Change from Baseline to 10 weeks
Resting Motor Threshold (rMT)
Time frame: Change from Baseline to 10 weeks
Active Motor Threshold (aMT)
Time frame: Change from Baseline to 10 weeks
MEP latency (resting)
Time frame: Change from Baseline to 10 weeks
MEP latency (active)
Time frame: Change from Baseline to 10 weeks
MEP amplitude (resting)
Time frame: Change from Baseline to 10 weeks
MEP amplitude (active)
Time frame: Change from Baseline to 10 weeks
Short-interval intracortical Inhibition (SICI)
Time frame: Change from Baseline to 10 weeks
Intracortical facilitation (ICF)
Time frame: Change from Baseline to 10 weeks
Cortical Silent Period (CSP)
Time frame: Change from Baseline to 10 weeks
Central Motor Conduction Time (CMCT)
Time frame: Change from Baseline to 10 weeks
EEG-EMG coherence (0-1)
Time frame: Change from Baseline to 10 weeks
Timed 25 feet walk test (T25FWT)
Time frame: Change from Baseline to 10 weeks
6-minute walk test (6MWT)
Time frame: Change from Baseline to 10 weeks
Six spot step test (SSST)
Time frame: Change from Baseline to 10 weeks
5 sit-to-stand (5STS)
Time frame: Change from Baseline to 10 weeks
9-step stair ascend (9SSA)
Time frame: Change from Baseline to 10 weeks
Patient determined disease steps (PDDS)
Time frame: Change from Baseline to 10 weeks
Multiple Sclerosis Walking Scale (MSWS)
Time frame: Change from Baseline to 10 weeks
Modified fatigue impact scale (MFIS)
Time frame: Change from Baseline to 10 weeks
MS impact scale (MSIS)
Time frame: Change from Baseline to 10 weeks
Falls-efficacy scale - international (FES-1)
Time frame: Change from Baseline to 10 weeks
The Physical Activity Enjoyment Scale (PACES)
Time frame: Change from Baseline to 10 weeks
Brief pain inventory (BPI)
Time frame: Change from Baseline to 10 weeks
Baecke physical activity
Time frame: Change from Baseline to 10 weeks
Accelerometry
Time frame: Change from Baseline to 10 weeks
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 11 Dec 2024.
- Derived from this study: PubMed 41991058Andersen TM, Riis H, Tankisi H, Mamoei S, Langeskov-Christensen M, Dalgas U, Lundbye-Jensen J, Hvid LG. Effects of supervised progressive resistance training on corticospinal excitability in persons with multiple sclerosis: A randomized controlled trial protocol for the NEXIMS study. Contemp Clin Trials. 2026 Jun;165:108317. doi: 10.1016/j.cct.2026.108317. Epub 2026 Apr 15.
Related trials for Multiple Sclerosis
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
RecruitingPhase 4
A Study of Ocrelizumab Administered Subcutaneously in Participants With Multiple Sclerosis Who Switch From an Approved Anti-CD20 Therapy
Multiple Sclerosis
RecruitingObservational study
Switch to Ofatumumab and Level of Immunoglobulins
Multiple Sclerosis
RecruitingObservational study
Non-interventional Study of Subcutaneous Ocrelizumab in Persons With Relapsing-Remitting Multiple Sclerosis
Relapsing-Remitting Multiple Sclerosis
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive resistance training in people with Multiple Sclerosis, run by University of Aarhus at 2 sites in Denmark.
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 4 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: looking for participants now, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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 Lars Hvid, PhD (93508717, lhvid@ph.au.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MEP/Mmax ratio (time frame: Change from Baseline to 10 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 NCT06374108, 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 11 Dec 2024; AzTrials last refreshed its copy on 1 Nov 2026.