Multiple SclerosisNCT02571335
Impacts of Different Training Modes (Intense Versus Ordinary) on the Immune System and Memory Functions in pwMS
A study testing Intensive Training and Normal Training in people with Multiple Sclerosis, run by Klinik Valens at 1 site in Switzerland.
Trial summary
Multiple Sclerosis (MS) is a chronic immune-mediated disease of the central nervous system, accompanied by varying inflammatory manifestations, demyelinization and axonal loss. With chronic progressive or relapsing-remitting disease onsets persons with MS (pwMS) progressively develop impaired functional capacity and… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Intensive Training and Normal Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2015to Aug 2016
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Key inclusion criteria for the participants' eligibility are a definite MS diagnosis (McDonald criteria). Participants fulfilling the key inclusion and the following criteria are eligible for this study
- EDSS 1.0 - 6.0
- Age 19 - 75 years
- The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- Persistent infections
- Severe cardiovascular and pulmonal diseases (renal failure, hepatic dysfunction, cardiovascular disease)
Show all 26Show fewer
- Severe cardiovascular exacerbations (RR > 240/120, HR above the age predicted maximum of 220-Age) during training
- Immunosuppressive therapy the day of CPET
- Life style factors and / or persistent addictions (drug or alcohol abuse)
- Inability to follow the study procedures (due to psychological disorders or dementia)
- Insufficient knowledge of the project language (German)
- Women who are pregnant or breast feeding,
- Intention to become pregnant during the course of the study,
- Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- Participation in another study with investigational drug within the 30 days preceding and during the present study,
- Previous enrolment into the current study,
- Enrolment of the investigator, his / her family members, employees and other dependent persons,
- Specific exclusions for the disease under study,
- Specific concomitant therapy washout requirements prior to and/or during study participation,
- Dietary restrictions
- Exclusion Criteria: Criteria in which the participant withdraws from this study may be the following:
- Inability to comply with the daily schedule
- Strong symptom exacerbations
- Withdrawal of informed consent
- Non-compliance
- Disease progression or relapse
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensity-dependent Impacts of Training on Growth Factors BDNF and Cognitive Functions in Persons With Multiple Sclerosis - a Single-center Randomized Controlled Trial
Multiple Sclerosis (MS) is a chronic immune-mediated disease of the central nervous system, accompanied by varying inflammatory manifestations, demyelinization and axonal loss. With chronic progressive or relapsing-remitting disease onsets persons with MS (pwMS) progressively develop impaired functional capacity and show reduced physical activity and cognitive decline compared to healthy controls. The primary aims of rehabilitation in pwMS are therefore to increase levels of activity and participation leading to increase independence of the participants. In general exercise ranges from passive physiotherapy-based interventions to submaximal endurance training sessions. Current recommendations advise pwMS that exercise should be matched with the individual performance capacities. Exercise training in pwMS then has the potential to target and improve many components outlined in the ICF-model.
Cytokines and neurotrophic factors have received increased attention in MS research and addressed the brain-derived neurotrophic factor (BDNF) as an important mediator of neuronal regeneration linking the effects of exercise with MS pathogenesis. Data show positive connections between elevated neurotrophin concentrations, induction of neuroplasticity, recovery of the motor and cognitive functions and the applied training intensities. Similarly, intensive and progressive exercise bouts seem to have greater benefits on cardiorespiratory fitness and maximum voluntary strength in elderly and seniors with dementia. Therefore, specific exercise prescriptions may be necessary for targeting the specific impairments also in pwMS.
Read more
This study aims to evaluate two different training modalities (intensive versus normal) in pwMS. It is expected that both modalities will improve cardiorespiratory fitness and cognitive functions in pwMS. Based on the findings that higher training intensities facilitate greater benefits, it is expected that pwMS will tolerate the intensive training intensities and show positive connections to elevated neurotrophin concentrations.
The results will to help to clearer understand the benefits of each type of exercise conveyed for pwMS and will assist in the development of patient-specific exercise prescriptions.
Read the detailed description
This study aims to evaluate two different training modalities (intensive versus normal) in pwMS. It is expected that both modalities will improve cardiorespiratory fitness and cognitive functions in pwMS. Based on the findings that higher training intensities facilitate greater benefits, it is expected that pwMS will tolerate the intensive training intensities and show positive connections to elevated neurotrophin concentrations.
Primary outcomes are the acute (after CPET) and chronic (3-week training intervention) changes of neurotrophic factors and cognitive functions. All other measures are secondary outcomes (Training values: VO2peak, Workload, Heart rate; Fatigue: FSMC; Anxiety and Depression: HADS.
Participants are eligible if they hold a definite diagnosis of multiple sclerosis (revised McDonald criteria), an EDSS score of 1.0 -6.0, they give no written consent, severe cardiovascular exacerbations (RR > 240/120, HR above the age predicted maximum of 220-Age) are persistent, they hold severe cognitive impairments, they face severe disease progression or relapses.
Main measurements and procedures include:
Blood sampling: Blood samples (10ml) of the primary outcomes will be taken by vein puncture from the antecubital vein in a seated position before the exercise bout and straight after reaching VO2peak during cool down, with the participant still seated on the ergometer.
Before samples are taken the participant will be required to relax for 10 minutes, blood sampling will take approximately 5 minutes.
Cardiopulmonary Exercise Test (CPET): Cardiorespiratory fitness is assessed through a progressive CPET performed at baseline on a cycle ergometer at t1 and is repeated the day prior to discharge at t2.
The exercise protocol consists of (a) first 3 minutes at rest (no pedalling) on the cycle ergometer; (b) 3 minutes of unloaded pedalling as a warm up; (c) testing phase until the participant reaches a symptom limited maximum. Workload is continuously ramp type increased by 5-10 Watts every minute to ensure 8-12 minutes of testing; (d) the final 3 minutes are unloaded pedalling to cool down. Heart rate (Polar Electro, Kempele, Finland) and blood pressure (Riva-Rocci) are monitored for the last 10 seconds every 2 minutes during the test. The 10-point BORG scale therapy short-form assesses the rate of perceived exertion (RPE) at phases (c) and (d). Blood samples are drawn at rest prior to phase (a) and at the end of CPET phase (d) at t1 and t2
Cognitive assessments: Cognitive assessments will be performed using the German version of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS). Additionally, the German version of the Trail-Making-Pencil-Test versions A/B (TMT-A/B) and Go/noGo (TAP version) will be used. Cognitive assessments will be performed at baseline (t1) and repeated at t2.
Fatigue: Fatigue is assessed with the multidimensional FSMC scale before CPET under resting conditions. FSMC has defined cut-off scores to classify mildly, moderately and severely fatigued patients. Cut-off for fatigue is set for the total score at 43 and for the motoric and cognitive sub-scores at 22. The scale has a proven test-retest liability and has been translated into multiple languages.
Depression and Anxiety: Depression and anxiety are assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-assessment questionnaire for adults with physical ailments that assess anxiety and depression. The questionnaire consists of 14 items seven for anxiety seven for depression with higher scores indicating anxiety or depression.
Training: Endurance training in both groups consisted of physiologically defined heart rate controlled cycling at 50-60 rounds per minutes (rpm) and progressive resistance training. All participants will be stratified according to their cardiorespiratory fitness and level of cognitive fatigue in to group Intensive Training (IT) and Normal Training (NT). Training groups differ in the applied intensities and frequencies.
The IT will train less frequent but training sessions will be more intensive in its effects. Training will be performed daily in six sessions (three morning and three afternoon sessions), synchronized and individually matched to a ratio of active versus passive sessions of 2:1.
The NT is the normal training performed out of the daily routine and outlines the usual care of the Valens clinic. Training will be performed in maximal eight training sessions and will not be synchronized and not individually matched to a ratio of active versus passive sessions.
- Conditions
- Multiple Sclerosis
- Being tested
- Intensive Training, Normal 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.
Intensive TrainingBehavioural
Also called Endurance and Resistance Training
Week 1: Ratio of continuous and interval training of 2:1. Entry point at day one with 20 min of continuous, physiologically defined heart rate controlled cycling at 50-60 rounds per minutes at 75% of HRpeak.
Resistance training is performed with 70% of the subjective-felt 1-round maximum with three sets and 10-12 repetitions and three exercises for the upper and lower extremities.
Week 2 Progression of endurance training: 4x5 minutes with 2 Minutes between each interval performed at 80% of HRmax Progression resistance training: 75% of the subjective-felt 1-round maximum with three sets and 8-10 repetitions and three exercises for the upper and lower extremities.
Week 3 Same as week 2.
Normal TrainingBehavioural
Also called Endurance and Resistance Training
The control intervention is the normal rehabilitation program of the Valens clinic.
| Study group | Role | What they receive |
|---|---|---|
| Intensive Training | Experimental | Treatment consists of endurance training in both groups of physiologically defined heart rate controlled cycling at 50-60 rounds per minutes (rpm) and progressive resistance training. Training groups differ in the applied intensities and frequencies.The IT will train less frequent but training sessions will be more intensive in its effects. Training will be performed daily in six sessions (three morning and three afternoon sessions), synchronized and individually matched to a ratio of active versus passive sessions of 2:1. Receives: Behavioral: Intensive Training |
| Normal Training | Active comparator | The NT is the normal training performed out of the daily routine and outlines the usual care of the Valens clinic. Training will be performed in up to eight training sessions that will not be synchronized and not individually matched to a ratio of active versus passive sessions. Receives: Behavioral: Normal Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurotrophic Factor BDNF
Short- and long-term changes (pg/ml) of serum levels of the neurotrophic factor BDNF (t1-->t2)
Measured: 3-weeks
Secondary outcomes (6)
Maximum Oxygen consumption (VO2peak)
workload (W) achieved in the cardiopulmonary exercise test.
Measured: 3-weeks
Maximum heart rate (HRmax)
Changes in beats min-1 over three weeks training
Measured: 3-weeks
Maximum workload (Loadmax)
Changes in Watt over three weeks training
Measured: 3-weeks
Fatigue
Changes over three weeks Training of Motor and Cognitive fatigue (Cut-off for fatigue is set for the total score at 43 and for the motoric and cognitive subscores at 22).
Measured: 3-weeks
Health-related Quality of life
Changes of anxiety and Depression over three weeks Training (Cut off for anxiety and Depression are set at 4 Points
Measured: 3-weeks
Cognitive Functions
Cognitive functions will be the changes on the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) and the Trail-Making-Pencil-Test versions A/B (TMT-A/B) both performed at baseline (t1) and repeated at t2
Measured: 3-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
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.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinik Valens
- Sponsor type
- University, hospital or other
- Collaborators
- German Sport University, Cologne
- Responsible party
- Principal investigator, Jens Bansi, Klinik Valens
- Investigators
- Juerg Kesselring, Prof, Study chair, Klinik Valens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02571335
- Sponsor's protocol ID
- JBansi
- Status last verified
- Aug 2016
- First submitted
- 23 Sep 2015
- Last updated
- 30 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Zimmer P, Bloch W, Schenk A, Oberste M, Riedel S, Kool J, Langdon D, Dalgas U, Kesselring J, Bansi J. High-intensity interval exercise improves cognitive performance and reduces matrix metalloproteinases-2 serum levels in persons with multiple sclerosis: A randomized controlled trial. Mult Scler. 2018 Oct;24(12):1635-1644. doi: 10.1177/1352458517728342. Epub 2017 Aug 21.
PubMed 28825348
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensity-dependent Impacts of Training on Growth Factors BDNF and Cognitive Functions in Persons With Multiple Sclerosis - a Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02571335
- Acronym / sponsor ID
- JBansi
- Conditions
- Multiple Sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Klinik ValensUniversity, hospital or other
- Collaborators
- German Sport University, Cologne
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 8 Oct 2015 (estimated)
- 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.
Multiple Sclerosis (MS) is a chronic immune-mediated disease of the central nervous system, accompanied by varying inflammatory manifestations, demyelinization and axonal loss. With chronic progressive or relapsing-remitting disease onsets persons with MS (pwMS) progressively develop impaired functional capacity and show reduced physical activity and cognitive decline compared to healthy controls. The primary aims of rehabilitation in pwMS are therefore to increase levels of activity and participation leading to increase independence of the participants. In general exercise ranges from passive physiotherapy-based interventions to submaximal endurance training sessions. Current recommendations advise pwMS that exercise should be matched with the individual performance capacities. Exercise training in pwMS then has the potential to target and improve many components outlined in the ICF-model.
Cytokines and neurotrophic factors have received increased attention in MS research and addressed the brain-derived neurotrophic factor (BDNF) as an important mediator of neuronal regeneration linking the effects of exercise with MS pathogenesis. Data show positive connections between elevated neurotrophin concentrations, induction of neuroplasticity, recovery of the motor and cognitive functions and the applied training intensities. Similarly, intensive and progressive exercise bouts seem to have greater benefits on cardiorespiratory fitness and maximum voluntary strength in elderly and seniors with dementia. Therefore, specific exercise prescriptions may be necessary for targeting the specific impairments also in pwMS.
This study aims to evaluate two different training modalities (intensive versus normal) in pwMS. It is expected that both modalities will improve cardiorespiratory fitness and cognitive functions in pwMS. Based on the findings that higher training intensities facilitate greater benefits, it is expected that pwMS will tolerate the intensive training intensities and show positive connections to elevated neurotrophin concentrations.
The results will to help to clearer understand the benefits of each type of exercise conveyed for pwMS and will assist in the development of patient-specific exercise prescriptions.
Detailed description
This study aims to evaluate two different training modalities (intensive versus normal) in pwMS. It is expected that both modalities will improve cardiorespiratory fitness and cognitive functions in pwMS. Based on the findings that higher training intensities facilitate greater benefits, it is expected that pwMS will tolerate the intensive training intensities and show positive connections to elevated neurotrophin concentrations.
Primary outcomes are the acute (after CPET) and chronic (3-week training intervention) changes of neurotrophic factors and cognitive functions. All other measures are secondary outcomes (Training values: VO2peak, Workload, Heart rate; Fatigue: FSMC; Anxiety and Depression: HADS.
Participants are eligible if they hold a definite diagnosis of multiple sclerosis (revised McDonald criteria), an EDSS score of 1.0 -6.0, they give no written consent, severe cardiovascular exacerbations (RR > 240/120, HR above the age predicted maximum of 220-Age) are persistent, they hold severe cognitive impairments, they face severe disease progression or relapses.
Main measurements and procedures include:
Blood sampling: Blood samples (10ml) of the primary outcomes will be taken by vein puncture from the antecubital vein in a seated position before the exercise bout and straight after reaching VO2peak during cool down, with the participant still seated on the ergometer.
Before samples are taken the participant will be required to relax for 10 minutes, blood sampling will take approximately 5 minutes.
Cardiopulmonary Exercise Test (CPET): Cardiorespiratory fitness is assessed through a progressive CPET performed at baseline on a cycle ergometer at t1 and is repeated the day prior to discharge at t2.
The exercise protocol consists of (a) first 3 minutes at rest (no pedalling) on the cycle ergometer; (b) 3 minutes of unloaded pedalling as a warm up; (c) testing phase until the participant reaches a symptom limited maximum. Workload is continuously ramp type increased by 5-10 Watts every minute to ensure 8-12 minutes of testing; (d) the final 3 minutes are unloaded pedalling to cool down. Heart rate (Polar Electro, Kempele, Finland) and blood pressure (Riva-Rocci) are monitored for the last 10 seconds every 2 minutes during the test. The 10-point BORG scale therapy short-form assesses the rate of perceived exertion (RPE) at phases (c) and (d). Blood samples are drawn at rest prior to phase (a) and at the end of CPET phase (d) at t1 and t2
Cognitive assessments: Cognitive assessments will be performed using the German version of the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS). Additionally, the German version of the Trail-Making-Pencil-Test versions A/B (TMT-A/B) and Go/noGo (TAP version) will be used. Cognitive assessments will be performed at baseline (t1) and repeated at t2.
Fatigue: Fatigue is assessed with the multidimensional FSMC scale before CPET under resting conditions. FSMC has defined cut-off scores to classify mildly, moderately and severely fatigued patients. Cut-off for fatigue is set for the total score at 43 and for the motoric and cognitive sub-scores at 22. The scale has a proven test-retest liability and has been translated into multiple languages.
Depression and Anxiety: Depression and anxiety are assessed with the Hospital Anxiety and Depression Scale (HADS). The HADS is a self-assessment questionnaire for adults with physical ailments that assess anxiety and depression. The questionnaire consists of 14 items seven for anxiety seven for depression with higher scores indicating anxiety or depression.
Training: Endurance training in both groups consisted of physiologically defined heart rate controlled cycling at 50-60 rounds per minutes (rpm) and progressive resistance training. All participants will be stratified according to their cardiorespiratory fitness and level of cognitive fatigue in to group Intensive Training (IT) and Normal Training (NT). Training groups differ in the applied intensities and frequencies.
The IT will train less frequent but training sessions will be more intensive in its effects. Training will be performed daily in six sessions (three morning and three afternoon sessions), synchronized and individually matched to a ratio of active versus passive sessions of 2:1.
The NT is the normal training performed out of the daily routine and outlines the usual care of the Valens clinic. Training will be performed in maximal eight training sessions and will not be synchronized and not individually matched to a ratio of active versus passive sessions.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Training | Experimental | Behavioral: Intensive TrainingTreatment consists of endurance training in both groups of physiologically defined heart rate controlled cycling at 50-60 rounds per minutes (rpm) and progressive resistance training. Training groups differ in the applied intensities and frequencies.The IT will train less frequent but training sessions will be more intensive in its effects. Training will be performed daily in six sessions (three morning and three afternoon sessions), synchronized and individually matched to a ratio of active versus passive sessions of 2:1. |
| Normal Training | Active comparator | Behavioral: Normal TrainingThe NT is the normal training performed out of the daily routine and outlines the usual care of the Valens clinic. Training will be performed in up to eight training sessions that will not be synchronized and not individually matched to a ratio of active versus passive sessions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Key inclusion criteria for the participants' eligibility are a definite MS diagnosis (McDonald criteria). Participants fulfilling the key inclusion and the following criteria are eligible for this study
- EDSS 1.0 - 6.0
- Age 19 - 75 years
- The presence of any one of the following exclusion criteria will lead to exclusion of the participant:
- Persistent infections
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Intensive TrainingAlso: Endurance and Resistance TrainingWeek 1: Ratio of continuous and interval training of 2:1. Entry point at day one with 20 min of continuous, physiologically defined heart rate controlled cycling at 50-60 rounds per minutes at 75% of HRpeak. Resistance training is performed with 70% of the subjective-felt 1-round maximum with three sets and 10-12 repetitions and three exercises for the upper and lower extremities. Week 2 Progression of endurance training: 4x5 minutes with 2 Minutes between each interval performed at 80% of HRmax Progression resistance training: 75% of the subjective-felt 1-round maximum with three sets and 8-10 repetitions and three exercises for the upper and lower extremities. Week 3 Same as week 2. | Behavioural | Intensive Training |
| Normal TrainingAlso: Endurance and Resistance TrainingThe control intervention is the normal rehabilitation program of the Valens clinic. | Behavioural | Normal Training |
Primary outcome
Neurotrophic Factor BDNF
Time frame: 3-weeks
Short- and long-term changes (pg/ml) of serum levels of the neurotrophic factor BDNF (t1-->t2)
6 secondary outcomes
Maximum Oxygen consumption (VO2peak)
Time frame: 3-weeks
Maximum heart rate (HRmax)
Time frame: 3-weeks
Maximum workload (Loadmax)
Time frame: 3-weeks
Fatigue
Time frame: 3-weeks
Health-related Quality of life
Time frame: 3-weeks
Cognitive Functions
Time frame: 3-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 30 Aug 2016.
- Derived from this study: PubMed 28825348Zimmer P, Bloch W, Schenk A, Oberste M, Riedel S, Kool J, Langdon D, Dalgas U, Kesselring J, Bansi J. High-intensity interval exercise improves cognitive performance and reduces matrix metalloproteinases-2 serum levels in persons with multiple sclerosis: A randomized controlled trial. Mult Scler. 2018 Oct;24(12):1635-1644. doi: 10.1177/1352458517728342. Epub 2017 Aug 21.
- 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.
Juerg Kesselring, Prof study chair
Klinik Valens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Training and Normal Training in people with Multiple Sclerosis, run by Klinik Valens at 1 site in Switzerland.
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 26 inclusion and 0 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 30 Aug 2016. 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 Switzerland. 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?
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?
Neurotrophic Factor BDNF (time frame: 3-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 NCT02571335, 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 30 Aug 2016.