Parkinson DiseaseNCT02125032
Transcranial Low Voltage Pulsed Electromagnetic Fields (T-PEMF) in Patients With Parkinson's Disease
A study testing Transcranial low voltage pulsed electromagnetic fields (T-PEMF) in people with Parkinson Disease, run by Odense University Hospital at 1 site in Denmark.
Trial summary
The aim of this study, is to determine whether treatment using transcranial low voltage pulsed electromagnetic fields (T-PEMF) can reduce the symptoms patients with Parkinson's Disease (PD) experience. The symptoms include movement, mentality and the nervous system in general. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Transcranial low voltage pulsed electromagnetic fields (T-PEMF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteDenmark
- Study dates
- May 2014to Mar 2018
- 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
- Patients with Idiopathic Parkinson's disease H \& Y 1-3 (Hoehn\&Yahr)
- MMSE > 22 (a screening test for dementia). (MMSE - Mini-Mental State Examination)
- Age > 18 years.
- The patient is capable understanding, accepting and complete the planned procedures.
Who cannot join
- The patient has been using T-PEMF before.
- Changes in anti-parkinson drug treatment within the last 6 weeks
- Noticeable dementia or other brain injury, which may affect the ability to give consent, or complicates the assessment of the patient
- Psychosis, or other psychopathological conditions, which requires intervention
- The abuse of alcohol or drugs
- Treatment with Deep Brain stimulation.
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- Pregnancy or nursing
- Epilepsy.
- Active implants such as pacemakers and others for example cochlear implants
- Active medical device for example insulin pumps, baclofen pumps.
- Participation in other trials in the intervention period
- Current or previous history of brain tumors, leukemia, malignant melanoma, skin cancer, or head and neck cancer
- Autoimmune disease
- Wounds in the scalp
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this study, is to determine whether treatment using transcranial low voltage pulsed electromagnetic fields (T-PEMF) can reduce the symptoms patients with Parkinson's Disease (PD) experience. The symptoms include movement, mentality and the nervous system in general.
Furthermore the purpose of this study is to clarify whether a group of patients with PD, gain a statistical improvement in their symptoms when treated with active T-PEMF, compared to a group of patients with PD who receive placebo T-PEMF .
- Conditions
- Parkinson Disease
- Being tested
- Transcranial low voltage pulsed electromagnetic fields (T-PEMF), Placebo Transcranial low voltage electromagnetic fields
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial low voltage pulsed electromagnetic fields (T-PEMF)Device
Also called The device name is: Re5 - Parkinson Treatment System
Placebo Transcranial low voltage electromagnetic fieldsDevice
Also called The devise name is: Re5 - Parkinson Treatment System
| Study group | Role | What they receive |
|---|---|---|
| Transcranial pulsed electromagnetic fields (T-PEMF) | Active comparator | One group receives 8 weeks of active T-PEMF treatment and another group receives 8 weeks of placebo T-PEMF. Both treatments to be performed 30 minutes once a day. Receives: Device: Transcranial low voltage pulsed electromagnetic fields (T-PEMF) |
| Trancranial electromagnetic pulsed fields (T-PEMF) | Placebo comparator | 8 weeks of T-PEMF treatment placebo. Receives: Device: Placebo Transcranial low voltage electromagnetic fields |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Unified Parkinson´s Disease Rating Scale (UPDRS)
Comment on "Title": It is expected that the outcome measure UPDRS will report a change after 8 weeks of treatment compared to baseline.
Comment on "Time Frame": Data will be assessed at each group after 8 weeks, and will be presented when all included patients have received their intervention.
Measured: At baseline and at endpoint at week 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionOct 2017
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Odense University 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Odense University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Mohr Morberg, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02125032
- Sponsor's protocol ID
- T-PEMF14
- Other IDs
- CIV-14-01-011780
- Status last verified
- Mar 2020
- First submitted
- 23 Apr 2014
- Last updated
- 5 Mar 2020
- Results posted
- No
Publications
Malling ASB, Morberg BM, Wermuth L, Gredal O, Bech P, Jensen BR. The effect of 8 weeks of treatment with transcranial pulsed electromagnetic fields on hand tremor and inter-hand coherence in persons with Parkinson's disease. J Neuroeng Rehabil. 2019 Jan 31;16(1):19. doi: 10.1186/s12984-019-0491-2.
PubMed 30704504Morberg BM, Malling AS, Jensen BR, Gredal O, Bech P, Wermuth L. Effects of transcranial pulsed electromagnetic field stimulation on quality of life in Parkinson's disease. Eur J Neurol. 2018 Jul;25(7):963-e74. doi: 10.1111/ene.13637. Epub 2018 Apr 17.
PubMed 29573167
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcranial Low Voltage Pulsed Electromagnetic Fields (T-PEMF) in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02125032
- Acronym / sponsor ID
- T-PEMF14
- Conditions
- Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Odense University HospitalUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Oct 2017 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 29 Apr 2014 (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.
The aim of this study, is to determine whether treatment using transcranial low voltage pulsed electromagnetic fields (T-PEMF) can reduce the symptoms patients with Parkinson's Disease (PD) experience. The symptoms include movement, mentality and the nervous system in general.
Furthermore the purpose of this study is to clarify whether a group of patients with PD, gain a statistical improvement in their symptoms when treated with active T-PEMF, compared to a group of patients with PD who receive placebo T-PEMF .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial pulsed electromagnetic fields (T-PEMF) | Active comparator | Device: Transcranial low voltage pulsed electromagnetic fields (T-PEMF)One group receives 8 weeks of active T-PEMF treatment and another group receives 8 weeks of placebo T-PEMF. Both treatments to be performed 30 minutes once a day. |
| Trancranial electromagnetic pulsed fields (T-PEMF) | Placebo comparator | Device: Placebo Transcranial low voltage electromagnetic fields8 weeks of T-PEMF treatment placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with Idiopathic Parkinson's disease H \& Y 1-3 (Hoehn\&Yahr)
- MMSE > 22 (a screening test for dementia). (MMSE - Mini-Mental State Examination)
- Age > 18 years.
- The patient is capable understanding, accepting and complete the planned procedures.
Key exclusion criteria (14 listed)
- The patient has been using T-PEMF before.
- Changes in anti-parkinson drug treatment within the last 6 weeks
- Noticeable dementia or other brain injury, which may affect the ability to give consent, or complicates the assessment of the patient
- Psychosis, or other psychopathological conditions, which requires intervention
- The abuse of alcohol or drugs
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 |
|---|---|---|
| Transcranial low voltage pulsed electromagnetic fields (T-PEMF)Also: The device name is: Re5 - Parkinson Treatment System | Device | Transcranial pulsed electromagnetic fields (T-PEMF) |
| Placebo Transcranial low voltage electromagnetic fieldsAlso: The devise name is: Re5 - Parkinson Treatment System | Device | Trancranial electromagnetic pulsed fields (T-PEMF) |
Primary outcome
Change from baseline in Unified Parkinson´s Disease Rating Scale (UPDRS)
Time frame: At baseline and at endpoint at week 8.
Comment on "Title": It is expected that the outcome measure UPDRS will report a change after 8 weeks of treatment compared to baseline. Comment on "Time Frame": Data will be assessed at each group after 8 weeks, and will be presented when all included patients have received their intervention.
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 5 Mar 2020.
- Derived from this study: PubMed 30704504Malling ASB, Morberg BM, Wermuth L, Gredal O, Bech P, Jensen BR. The effect of 8 weeks of treatment with transcranial pulsed electromagnetic fields on hand tremor and inter-hand coherence in persons with Parkinson's disease. J Neuroeng Rehabil. 2019 Jan 31;16(1):19. doi: 10.1186/s12984-019-0491-2.
- Derived from this study: PubMed 29573167Morberg BM, Malling AS, Jensen BR, Gredal O, Bech P, Wermuth L. Effects of transcranial pulsed electromagnetic field stimulation on quality of life in Parkinson's disease. Eur J Neurol. 2018 Jul;25(7):963-e74. doi: 10.1111/ene.13637. Epub 2018 Apr 17.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial low voltage pulsed electromagnetic fields (T-PEMF) in people with Parkinson Disease, run by Odense University Hospital at 1 site 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 14 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 5 Mar 2020. 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 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. 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?
Change from baseline in Unified Parkinson´s Disease Rating Scale (UPDRS) (time frame: At baseline and at endpoint at week 8.). 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 NCT02125032, which also lists 2 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 5 Mar 2020.