Transcranial Magnetic StimulationNCT04439669
CRPS - Diagnostics, Pathophysiological Mechanisms, and Response to Treatment With Noninvasive Brain Stimulation
A study testing Active nrTMS and open phase in people with Transcranial Magnetic Stimulation and Complex Regional Pain Syndrome of Upper Limb (Disorder), run by Helsinki University Central Hospital at 2 sites in Finland.
Trial summary
This is a sham controlled, randomized, double-blind, navigated repetitive Transcranial Magnetic Stimulation (nrTMS) study for the treatment of complex regional pain syndrome (CRPS types 1 and 2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transcranial Magnetic Stimulation, Complex Regional Pain Syndrome of Upper Limb (Disorder)
- What is being tested?
- Active nrTMS and open phase
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 2 sitesFinland
- Study dates
- 28 Aug 2017to 25 Aug 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CRPS 1 or 2 of the upper limb
- Duration ≥ 6 months
- Mean pain (NRS) intensity ≥5/10
- Medical and other therapies have failed
Who cannot join
- Other stimulation therapies apart from transcutaneous nerve stimulation
- psychotic disorder
- severe depression
- use of strong opioids
- epilepsy
- any contraindication for MRI
- abuse of alcohol or drugs
- ongoing insurance or other entitlement cases
Trial locations and contacts
2 sites in 1 country.
Finland2 sites
Helsinki University Hospital, Pain Clinic
Helsinki, Uusimaa, 00029
Turku University Hospital, Pain Clinic
Turku, Southwest Finland, 20014
About this study
Official title: Complex Regional Pain Syndrome - Diagnostics, Pathophysiological Mechanisms, and Response to Treatment With Noninvasive Brain Stimulation
This is a sham controlled, randomized, double-blind, navigated repetitive Transcranial Magnetic Stimulation (nrTMS) study for the treatment of complex regional pain syndrome (CRPS types 1 and 2). The investigators study factors that may contribute to development, maintenance, or treatment responses with clinical, sleep, and psychiatric questionnaires and clinical examinations, quantitative sensory testing and neurophysiologic recordings, genetics, and MRI techniques.
Read the detailed description
rTMS hypothetically disrupts the default networks related to chronic pain and renders the brain more susceptible to drugs, rehabilitation, or cognitive behavioral therapy. In addition, there is experimental evidence that rTMS releases factors that are involved in endogenous top-down modulation of pain and neural plasticity. Thus, the analgesic effect of rTMS may be mediated via enforcing endogenous pain control systems at the brain level, in addition to its effects on neuroplastic effects.
For active, navigated stimulation targets the investigators have the parietal opercular cortex overlying the secondary somatosensory cortex ("S2") and the primary motor cortex (M1).
The investigators randomize participants to first receive nrTMS to the right "S2" or sham stimulation. After ten sessions the investigators follow up the participants up to three months. At three months, if the average pain is ≥5/10 in numeric rating scale (NRS), the participant is offered an active, open nrTMS treatment phase depending on which treatment the participant first received. If the participant benefits from the open label treatment, a maintenance therapy is offered (6 months with gradually reducing nrTMS treatment frequency). The symptoms and quality of life are followed with questionnaires and diaries. After the maintenance period, the RN calls a structured interview at 1, 3, and 6 months.
- Conditions
- Transcranial Magnetic Stimulation, Complex Regional Pain Syndrome of Upper Limb (Disorder)
- Being tested
- Sham nrTMS and open phase, Active nrTMS and open phase
- Keywords
- TMS, CRPS, pain, fMRI, quality of life, mood, cognitive function, DNA
- Medical subject headings
- Reflex Sympathetic Dystrophy, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham nrTMS and open phaseDevice
Also called Starts with sham stimulation
Navigated repetitive TMS treatment (10 sessions during a three-week period) randomized to sham. In the following open phase stimulation the treatment targets are the right "S2"-contralateral M1-left "S2".
Active nrTMS and open phaseDevice
Also called Starts with active stimulation
Navigated repetitive TMS treatment (10 sessions during a three-week period) randomized to "S2". In the following open phase stimulation the treatment targets are contralateral M1 and left "S2". If the patient benefited from active "S2" stimulation, but the treatment effect faded in follow-up, the open phase stimulation starts with right "S2".
| Study group | Role | What they receive |
|---|---|---|
| Starts with active stimulation | Active comparator | Active nrTMS is given to "S2" at the right side (10 sessions in a three week period). Thereafter, a new, open label phase will start if the average pain at 3 month follow-up is ≥5/10. Then, the nrTMS will be targeted to M1 contralateral to the side of pain. After 5 stimulation sessions the response is evaluated. If pain is still ≥510, the investigators change the target to the "S2" on the left side for five sessions. If there is response with pain relief, a maintenance therapy with this target is offered for 6 months with gradually reducing stimulation sessions. Receives: Device: Active nrTMS and open phase |
| Starts with sham stimulation | Placebo comparator | Sham nrTMS will be targeted to the "S2" on the right side, but using a sham box/coil. Stimulation period is similar than for the active comparator. Similarly, thereafter, a new, open label phase will start if the average pain at 3 month follow-up is ≥5/10. Then, the nrTMS will be targeted to "S2" at the right side. After 5 stimulation sessions the response is evaluated. If pain is still ≥5/10, the investigators change the target to M1 on the contralateral side of the pain and furthermore to "S2" at the left side after 5 stimulation sessions, if pain is still ≥5/10. Receives: Device: Sham nrTMS and open phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
15-item quality of life measure
Quality of life (15D questionnaire) with 15 question items with 5 alternatives in each. The scores range between 15 to 75 with 15 the best and 75 the worst quality of life.
Measured: Change from baseline at one month
Secondary outcomes (17)
Mean pain intensity and interference
Numeric rating scale (NRS, 0= no pain and 10= the worst pain imaginable)
Measured: Baseline, during stimulation, and two weeks after the intervention
Weekly pain intensity and interference
Pain questionnaires (numeric rating scale (NRS, 0= no pain and 10= the worst pain imaginable)
Measured: Up to 3 months after intervention
Sleep interference and quality
Insonnia severity index (ISI). There are seven questions with scale 0 to 4 (0 with no symptoms and 4 with the worst symptoms). The scores are added up to get a total score ranging from 0 to 28. A higher score means a worse outcome.
Measured: Baseline and 1,2,and 3 months after intervention
Clinical neurophysiology measures
Quantitative sensory testing (QST) with standardized reporting
Measured: Baseline and one week after intervention
Cognitive assessment A
Cognitive function assessment by Cogstate, a computer based detection and identification task. Answers yes or no, standard reporting.
Measured: Baseline and one month after the intervention
Hand strength
Hand motor function measured e.g. by Jamar (kg)
Measured: Baseline and one week after the intervention.
Biochemical tests
Blood samples: inflammatory markers (e.g. high sensitivity CRP, proteomics). Standard reporting
Measured: At baseline
Brain imaging: Default mode networks
Resting state fMRI
Measured: Baseline and one week after intervention
CRPS symptom severity
CRPS severity scale (CSS, 0=no symptoms or signs, 17=maximum score with symptoms and signs)
Measured: Baseline and at one month
Patient global impression of change
Global impression of change (GIC, 1=very much improved, 7= very much worse)
Measured: 1, 2, and 3 months and through study completion, an average of 1 year
Screening of psychiatric symptoms and diagnostics
Psychiatric interveiw (SCID II) with symptom and diagnostic description. Nine questions, answers yes or no, standard reporting. The more "yes"-answers, the worse the outcome.
Measured: Up to 24 weeks
Hand mobility
Angles of the joints in the hand (degrees)
Measured: Baseline and one week after intervention
Cognitive assessment B
Wechsler Memory Scale III (WMS-III) subtest: digit span. Number of digits recalled. Standard reporting.
Measured: Baseline and one month after the intervention
Cognitive assessment C
Wechsler Memory Scale III (WMS-III) subtest: word list. Number of words recalled. Standard reporting.
Measured: Baseline and one month after the intervention
Cognitive assessment D
Bourdon-Wiersma (Attention and concentration): number of visual stimuli found.
Measured: Baseline and one month after the intervention
Cognitive assesment E
Trail-Making Test (Parts A and B): time spent (seconds) for visual scanning task. Standard reporting.
Measured: Baseline and one month after the intervention
DNA
DNA analysis. Standard reporting.
Measured: At baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2020
- Study start28 Aug 2017
- Primary completion29 Jul 2021
- Study completion25 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Transcranial Magnetic StimulationStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Model description
- The patients are first randomized to receive either sham stimulation or right "S2" for three week period (10 stimulation sessions). Thereafter, a 3 month followup period (clinical checkup at a research visit at 1 month, RN structured telephone interviews at 2 and 3 months). If pain ≥5/10 at 3 month interview, the patient is offered an open label nrTMS treatment phase, in which the protocol depends on the first protocol of the RCT phase.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital
- Responsible party
- Principal investigator, Hanna Harno, Helsinki University Central Hospital
- Investigators
- Eija Kalso, Professor, Study chair, Helsinki University Hospital, Pain ClinicSatu Jääskeläinen, Professor, Study chair, Turku University Hospital, Dept. of Clinical NeurophysiologyHanna Harno, MD, PhD, Study director, Helsinki University Hospital, Pain Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04439669
- Sponsor's protocol ID
- TYH20162222
- Status last verified
- Jul 2024
- First submitted
- 31 Mar 2020
- Last updated
- 3 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The Ethics committee doesn't allow that due to privacy agreements.
Publications
Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
PubMed 31901449Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.
PubMed 25034472Jaaskelainen SK, Lindholm P, Valmunen T, Pesonen U, Taiminen T, Virtanen A, Lamusuo S, Forssell H, Hagelberg N, Hietala J, Pertovaara A. Variation in the dopamine D2 receptor gene plays a key role in human pain and its modulation by transcranial magnetic stimulation. Pain. 2014 Oct;155(10):2180-7. doi: 10.1016/j.pain.2014.08.029. Epub 2014 Aug 29.
PubMed 25180011Liesto S, Aho T, Jaaskelainen SK, Hietanen M, Kalso E. Cognitive Function in Patients With Complex Regional Pain Syndrome (CRPS). Eur J Pain. 2025 Jul;29(6):e70070. doi: 10.1002/ejp.70070.
PubMed 40626344
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Regional Pain Syndrome - Diagnostics, Pathophysiological Mechanisms, and Response to Treatment With Noninvasive Brain Stimulation
- ClinicalTrials.gov ID
- NCT04439669
- Acronym / sponsor ID
- TYH20162222
- Conditions
- Transcranial Magnetic Stimulation, Complex Regional Pain Syndrome of Upper Limb (Disorder)
- Keywords
- TMS, CRPS, pain, fMRI, quality of life, mood, cognitive function, DNA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital
- Study start
- 28 Aug 2017 (actual)
- Primary completion
- 29 Jul 2021 (actual)
- Study completion
- 25 Aug 2022 (actual)
- First posted
- 19 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a sham controlled, randomized, double-blind, navigated repetitive Transcranial Magnetic Stimulation (nrTMS) study for the treatment of complex regional pain syndrome (CRPS types 1 and 2). The investigators study factors that may contribute to development, maintenance, or treatment responses with clinical, sleep, and psychiatric questionnaires and clinical examinations, quantitative sensory testing and neurophysiologic recordings, genetics, and MRI techniques.
Detailed description
rTMS hypothetically disrupts the default networks related to chronic pain and renders the brain more susceptible to drugs, rehabilitation, or cognitive behavioral therapy. In addition, there is experimental evidence that rTMS releases factors that are involved in endogenous top-down modulation of pain and neural plasticity. Thus, the analgesic effect of rTMS may be mediated via enforcing endogenous pain control systems at the brain level, in addition to its effects on neuroplastic effects.
For active, navigated stimulation targets the investigators have the parietal opercular cortex overlying the secondary somatosensory cortex ("S2") and the primary motor cortex (M1).
The investigators randomize participants to first receive nrTMS to the right "S2" or sham stimulation. After ten sessions the investigators follow up the participants up to three months. At three months, if the average pain is ≥5/10 in numeric rating scale (NRS), the participant is offered an active, open nrTMS treatment phase depending on which treatment the participant first received. If the participant benefits from the open label treatment, a maintenance therapy is offered (6 months with gradually reducing nrTMS treatment frequency). The symptoms and quality of life are followed with questionnaires and diaries. After the maintenance period, the RN calls a structured interview at 1, 3, and 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients are first randomized to receive either sham stimulation or right "S2" for three week period (10 stimulation sessions). Thereafter, a 3 month followup period (clinical checkup at a research visit at 1 month, RN structured telephone interviews at 2 and 3 months). If pain ≥5/10 at 3 month interview, the patient is offered an open label nrTMS treatment phase, in which the protocol depends on the first protocol of the RCT phase.
| Arm | Type | Receives |
|---|---|---|
| Starts with active stimulation | Active comparator | Device: Active nrTMS and open phaseActive nrTMS is given to "S2" at the right side (10 sessions in a three week period). Thereafter, a new, open label phase will start if the average pain at 3 month follow-up is ≥5/10. Then, the nrTMS will be targeted to M1 contralateral to the side of pain. After 5 stimulation sessions the response is evaluated. If pain is still ≥510, the investigators change the target to the "S2" on the left side for five sessions. If there is response with pain relief, a maintenance therapy with this target is offered for 6 months with gradually reducing stimulation sessions. |
| Starts with sham stimulation | Placebo comparator | Device: Sham nrTMS and open phaseSham nrTMS will be targeted to the "S2" on the right side, but using a sham box/coil. Stimulation period is similar than for the active comparator. Similarly, thereafter, a new, open label phase will start if the average pain at 3 month follow-up is ≥5/10. Then, the nrTMS will be targeted to "S2" at the right side. After 5 stimulation sessions the response is evaluated. If pain is still ≥5/10, the investigators change the target to M1 on the contralateral side of the pain and furthermore to "S2" at the left side after 5 stimulation sessions, if pain is still ≥5/10. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- CRPS 1 or 2 of the upper limb
- Duration ≥ 6 months
- Mean pain (NRS) intensity ≥5/10
- Medical and other therapies have failed
Key exclusion criteria (8 listed)
- Other stimulation therapies apart from transcutaneous nerve stimulation
- psychotic disorder
- severe depression
- use of strong opioids
- epilepsy
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 |
|---|---|---|
| Sham nrTMS and open phaseAlso: Starts with sham stimulationNavigated repetitive TMS treatment (10 sessions during a three-week period) randomized to sham. In the following open phase stimulation the treatment targets are the right "S2"-contralateral M1-left "S2". | Device | Starts with sham stimulation |
| Active nrTMS and open phaseAlso: Starts with active stimulationNavigated repetitive TMS treatment (10 sessions during a three-week period) randomized to "S2". In the following open phase stimulation the treatment targets are contralateral M1 and left "S2". If the patient benefited from active "S2" stimulation, but the treatment effect faded in follow-up, the open phase stimulation starts with right "S2". | Device | Starts with active stimulation |
Primary outcome
15-item quality of life measure
Time frame: Change from baseline at one month
Quality of life (15D questionnaire) with 15 question items with 5 alternatives in each. The scores range between 15 to 75 with 15 the best and 75 the worst quality of life.
17 secondary outcomes
Mean pain intensity and interference
Time frame: Baseline, during stimulation, and two weeks after the intervention
Weekly pain intensity and interference
Time frame: Up to 3 months after intervention
Sleep interference and quality
Time frame: Baseline and 1,2,and 3 months after intervention
Clinical neurophysiology measures
Time frame: Baseline and one week after intervention
Cognitive assessment A
Time frame: Baseline and one month after the intervention
Hand strength
Time frame: Baseline and one week after the intervention.
Biochemical tests
Time frame: At baseline
Brain imaging: Default mode networks
Time frame: Baseline and one week after intervention
CRPS symptom severity
Time frame: Baseline and at one month
Patient global impression of change
Time frame: 1, 2, and 3 months and through study completion, an average of 1 year
Screening of psychiatric symptoms and diagnostics
Time frame: Up to 24 weeks
Hand mobility
Time frame: Baseline and one week after intervention
Cognitive assessment B
Time frame: Baseline and one month after the intervention
Cognitive assessment C
Time frame: Baseline and one month after the intervention
Cognitive assessment D
Time frame: Baseline and one month after the intervention
Cognitive assesment E
Time frame: Baseline and one month after the intervention
DNA
Time frame: At baseline
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 3 Jul 2024.
- Background: PubMed 31901449Lefaucheur JP, Aleman A, Baeken C, Benninger DH, Brunelin J, Di Lazzaro V, Filipovic SR, Grefkes C, Hasan A, Hummel FC, Jaaskelainen SK, Langguth B, Leocani L, Londero A, Nardone R, Nguyen JP, Nyffeler T, Oliveira-Maia AJ, Oliviero A, Padberg F, Palm U, Paulus W, Poulet E, Quartarone A, Rachid F, Rektorova I, Rossi S, Sahlsten H, Schecklmann M, Szekely D, Ziemann U. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS): An update (2014-2018). Clin Neurophysiol. 2020 Feb;131(2):474-528. doi: 10.1016/j.clinph.2019.11.002. Epub 2020 Jan 1.
- Background: PubMed 25034472Lefaucheur JP, Andre-Obadia N, Antal A, Ayache SS, Baeken C, Benninger DH, Cantello RM, Cincotta M, de Carvalho M, De Ridder D, Devanne H, Di Lazzaro V, Filipovic SR, Hummel FC, Jaaskelainen SK, Kimiskidis VK, Koch G, Langguth B, Nyffeler T, Oliviero A, Padberg F, Poulet E, Rossi S, Rossini PM, Rothwell JC, Schonfeldt-Lecuona C, Siebner HR, Slotema CW, Stagg CJ, Valls-Sole J, Ziemann U, Paulus W, Garcia-Larrea L. Evidence-based guidelines on the therapeutic use of repetitive transcranial magnetic stimulation (rTMS). Clin Neurophysiol. 2014 Nov;125(11):2150-2206. doi: 10.1016/j.clinph.2014.05.021. Epub 2014 Jun 5.
- Background: PubMed 25180011Jaaskelainen SK, Lindholm P, Valmunen T, Pesonen U, Taiminen T, Virtanen A, Lamusuo S, Forssell H, Hagelberg N, Hietala J, Pertovaara A. Variation in the dopamine D2 receptor gene plays a key role in human pain and its modulation by transcranial magnetic stimulation. Pain. 2014 Oct;155(10):2180-7. doi: 10.1016/j.pain.2014.08.029. Epub 2014 Aug 29.
- Derived from this study: PubMed 40626344Liesto S, Aho T, Jaaskelainen SK, Hietanen M, Kalso E. Cognitive Function in Patients With Complex Regional Pain Syndrome (CRPS). Eur J Pain. 2025 Jul;29(6):e70070. doi: 10.1002/ejp.70070.
- Individual participant dataSharing planned: No. The Ethics committee doesn't allow that due to privacy agreements.
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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.
Eija Kalso, Professor study chair
Helsinki University Hospital, Pain Clinic
Satu Jääskeläinen, Professor study chair
Turku University Hospital, Dept. of Clinical Neurophysiology
Hanna Harno, MD, PhD study director
Helsinki University Hospital, Pain Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active nrTMS and open phase in people with Transcranial Magnetic Stimulation and Complex Regional Pain Syndrome of Upper Limb (Disorder), run by Helsinki University Central Hospital at 2 sites in Finland.
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 8 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 3 Jul 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 Finland. 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?
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?
15-item quality of life measure (time frame: Change from baseline at one month). 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 NCT04439669, which also lists 4 linked publications.
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 Jul 2024; AzTrials last refreshed its copy on 6 Nov 2026.