Parkinson DiseaseNCT04017481
Non Invasive Neuromodulation for Patients With Motor Control Disorders
A study testing Repetitive transcranial magnetic stimulation (rTMS) and EEG guided Neurofeedback (NFB) in people with Parkinson Disease, run by Universidad Francisco de Vitoria.
Trial summary
Movement disorders are neurological syndromes leading to excessive movements or to limited control of voluntary and automatic movements. Many of these disorders are not life-threatening but represent serious difficulties in carrying out the activities of daily living and reduce patient's independence and quality of… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS) and EEG guided Neurofeedback (NFB)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 30 Sep 2019
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Idiopathic Parkinsons Disease
- Hoehn Yahr Scale I-III
- No drug changes in the last 90 days
- No exclusion criteria
Who cannot join
- Dementia (Minimental scale score <25)
- Dependency (modified Rankin scale > 3)
- Pregnancy or pregnancy plans
- Pacemaker
- Implanted metal devices
- cochlear implants
Show all 13Show fewer
- claustrophobia
- drug infusion pumps
- epilepsy / epileptiform anomalies in electroencephalography (EEG)
- known structural alterations in magnetic resonance imaging (MRI)
- Atypical Parkinsonism
- Previous repetitive transcranial magnetic stimulation (rTMS)
- Severe comorbidity (cancer, severe debilitating diseases, etc.)
About this study
Official title: Development and Clinical Validation of a Rehabilitation Platform Based on Neuromodulation for Patients With Motor Control Disorders
Movement disorders are neurological syndromes leading to excessive movements or to limited control of voluntary and automatic movements. Many of these disorders are not life-threatening but represent serious difficulties in carrying out the activities of daily living and reduce patient's independence and quality of life.
This project NeuroMOD (neuromodulation for patients with disorders of motor control) proposes the development of a neuromodulation-based platform for the rehabilitation and restoration of motor and cognitive functions of patients suffering from Parkinson's disease (PD). Our project will focus on the application of a novel neurorehabilitation strategy, its functional and clinical validation, and on the evaluation of the impact of the use of the technologies involved in the musculoskeletal and the nervous system as well as user behavior.
Read more
Parkinson's disease was selected as target pathology since it represents a paradigm of motor disorder diseases.
Parkinson's disease affects adults and has a very high prevalence and a very high functional impact.
In order to achieve this objective, we have defined the following research areas:
Subproject 1. NeuroMOD: development of a neuromodulation platform composed by a TMS system, and an EMG (electromyography) and EEG (electroencephalography) system in combination with a system of virtual reality based on immersive glasses.
Subproject 2. NeuroMOD-PD: development of therapies and evaluation of clinical evidence and motor and cognitive impact of NeuroMOD in the rehabilitation of patients suffering from Parkinson's disease impact.
Subproject 3. NeuroMOD-Image: development of neuroimaging techniques to investigate the brain areas affected by the proposed therapies and temporary terms that neural plasticity is induced and evolves in Parkinson´s Disease.
- Conditions
- Parkinson Disease
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS), EEG guided Neurofeedback (NFB)
- Keywords
- neuromodulation, TMS, NFB
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Other
The intervention intends to change the cortical plasticity in specific cortical areas. rTMS is a non-invasive exogenous neuromodulation technique that uses repetitive magnetic pulses administered in a specific area of the head in order to influence the connectivity of the underlying brain area.
EEG guided Neurofeedback (NFB)Other
The intervention intends to change the cortical plasticity in specific cortical areas. The NFB is a non-invasive endogenous technique that seeks the self-regulation of cortical activity through the information represented in a videogame which is used to interact with the subject.
| Study group | Role | What they receive |
|---|---|---|
| Repetitive stimulating transcranial stimulation (rTMS) | Experimental | Subjects receive 8 sessions M1 Neuromodulation using rTMS according to the protocol ( 80% resting motor threshold, 10 Hertz; 1000 pulses; 25 trains de 4 seconds con 25 seconds intertrain. Receives: Other: Repetitive transcranial magnetic stimulation (rTMS) |
| EEG guided Neurofeedback (NFB) | Experimental | Subjects receive 8 sessions M1 EEG guided NFB with virtual reality goggles in order to modify the beta rhythm. The sessions have a duration of 20min Receives: Other: EEG guided Neurofeedback (NFB) |
| rTMS + NFB | Experimental | Subjects receive both interventions sequentially Receives: Other: Repetitive transcranial magnetic stimulation (rTMS); Other: EEG guided Neurofeedback (NFB) |
| No intervention | No intervention | No interventions, the patient just comes to be evaluated sequentially according to the timing of experimental groups. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor changes
UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) part III ( total values from 0-68, higher score worse clinical situation)
Measured: The day before the first stimulation session and 2 weeks after the first stimulation session
Motor changes
UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) part III ( total values from 0-68, higher score worse clinical situation)
Measured: t2(2 weeks after finishing the protocol)
Neurophysiological cortical changes
Cortical silent period measured using transcranial magnetic pulse in M1 and simultaneous register of electromyographical response
Measured: The day before the first stimulation session and 2 weeks after the first stimulation session
Neurophysiological cortical changes
Cortical silent period measured using transcranial magnetic pulse in M1 and simultaneous register of electromyographical response
Measured: t2(2 weeks after finishing the protocol)
Secondary outcomes (3)
Quality of life changes
Changes in PDQ 39 (The 39-Item Parkinson's Disease Questionnaire) score, common range of 0-100 (100 = maximum level of problems).
Measured: t2(2 weeks after finishing the protocol)
Encephalographic changes
Changes in microstates of electro encephalography (presence of state A, B, C, D and E)
Measured: t2(2 weeks after finishing the protocol)
Cognitive changes in objective measures of processing speed
Changes in cognitive processing speed using computer based reaction time task
Measured: t2(2 weeks after finishing the protocol)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start1 Sep 2016
- Primary completion20 Dec 2018
- Study completion30 Sep 2019
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 Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Each study participant is assigned to one of the arms. Four intervention groups are defined as rTMS only, NFB only, both TMS and NFB, or neither TMS or NFB
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Francisco de Vitoria
- Sponsor type
- University, hospital or other
- Collaborators
- National Research Council, Spain, Hospital Beata María Ana, Hospital Universitario de Fuenlabrada
- Responsible party
- Sponsor
- Investigators
- Juan Pablo Romero Muñoz, MD PhD, Principal investigator, Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04017481
- Sponsor's protocol ID
- NeuroMOD
- Status last verified
- Jul 2019
- First submitted
- 2 Jul 2019
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual anonymized participant data will be available to other researchers under request.
Publications
Romero JP, Moreno-Verdu M, Arroyo-Ferrer A, Serrano JI, Herreros-Rodriguez J, Garcia-Caldentey J, Rocon de Lima E, Del Castillo MD. Clinical and neurophysiological effects of bilateral repetitive transcranial magnetic stimulation and EEG-guided neurofeedback in Parkinson's disease: a randomized, four-arm controlled trial. J Neuroeng Rehabil. 2024 Aug 5;21(1):135. doi: 10.1186/s12984-024-01427-5.
PubMed 39103947
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Clinical Validation of a Rehabilitation Platform Based on Neuromodulation for Patients With Motor Control Disorders
- ClinicalTrials.gov ID
- NCT04017481
- Acronym / sponsor ID
- NeuroMOD
- Conditions
- Parkinson Disease
- Keywords
- neuromodulation, TMS, NFB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universidad Francisco de VitoriaUniversity, hospital or other
- Collaborators
- National Research Council, Spain, Hospital Beata María Ana, Hospital Universitario de Fuenlabrada
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 20 Dec 2018 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 12 Jul 2019 (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.
Movement disorders are neurological syndromes leading to excessive movements or to limited control of voluntary and automatic movements. Many of these disorders are not life-threatening but represent serious difficulties in carrying out the activities of daily living and reduce patient's independence and quality of life.
This project NeuroMOD (neuromodulation for patients with disorders of motor control) proposes the development of a neuromodulation-based platform for the rehabilitation and restoration of motor and cognitive functions of patients suffering from Parkinson's disease (PD). Our project will focus on the application of a novel neurorehabilitation strategy, its functional and clinical validation, and on the evaluation of the impact of the use of the technologies involved in the musculoskeletal and the nervous system as well as user behavior.
Parkinson's disease was selected as target pathology since it represents a paradigm of motor disorder diseases.
Parkinson's disease affects adults and has a very high prevalence and a very high functional impact.
In order to achieve this objective, we have defined the following research areas:
Subproject 1. NeuroMOD: development of a neuromodulation platform composed by a TMS system, and an EMG (electromyography) and EEG (electroencephalography) system in combination with a system of virtual reality based on immersive glasses.
Subproject 2. NeuroMOD-PD: development of therapies and evaluation of clinical evidence and motor and cognitive impact of NeuroMOD in the rehabilitation of patients suffering from Parkinson's disease impact.
Subproject 3. NeuroMOD-Image: development of neuroimaging techniques to investigate the brain areas affected by the proposed therapies and temporary terms that neural plasticity is induced and evolves in Parkinson´s Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Each study participant is assigned to one of the arms. Four intervention groups are defined as rTMS only, NFB only, both TMS and NFB, or neither TMS or NFB
| Arm | Type | Receives |
|---|---|---|
| Repetitive stimulating transcranial stimulation (rTMS) | Experimental | Other: Repetitive transcranial magnetic stimulation (rTMS)Subjects receive 8 sessions M1 Neuromodulation using rTMS according to the protocol ( 80% resting motor threshold, 10 Hertz; 1000 pulses; 25 trains de 4 seconds con 25 seconds intertrain. |
| EEG guided Neurofeedback (NFB) | Experimental | Other: EEG guided Neurofeedback (NFB)Subjects receive 8 sessions M1 EEG guided NFB with virtual reality goggles in order to modify the beta rhythm. The sessions have a duration of 20min |
| rTMS + NFB | Experimental | Other: Repetitive transcranial magnetic stimulation (rTMS), Other: EEG guided Neurofeedback (NFB)Subjects receive both interventions sequentially |
| No intervention | No intervention | –No interventions, the patient just comes to be evaluated sequentially according to the timing of experimental groups. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Idiopathic Parkinsons Disease
- Hoehn Yahr Scale I-III
- No drug changes in the last 90 days
- No exclusion criteria
Key exclusion criteria (13 listed)
- Dementia (Minimental scale score <25)
- Dependency (modified Rankin scale > 3)
- Pregnancy or pregnancy plans
- Pacemaker
- Implanted metal devices
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 |
|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS)The intervention intends to change the cortical plasticity in specific cortical areas. rTMS is a non-invasive exogenous neuromodulation technique that uses repetitive magnetic pulses administered in a specific area of the head in order to influence the connectivity of the underlying brain area. | Other | Repetitive stimulating transcranial stimulation (rTMS), rTMS + NFB |
| EEG guided Neurofeedback (NFB)The intervention intends to change the cortical plasticity in specific cortical areas. The NFB is a non-invasive endogenous technique that seeks the self-regulation of cortical activity through the information represented in a videogame which is used to interact with the subject. | Other | EEG guided Neurofeedback (NFB), rTMS + NFB |
Primary outcome
Motor changes
Time frame: The day before the first stimulation session and 2 weeks after the first stimulation session
UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) part III ( total values from 0-68, higher score worse clinical situation)
Motor changes
Time frame: t2(2 weeks after finishing the protocol)
UNIFIED PARKINSON'S DISEASE RATING SCALE (UPDRS) part III ( total values from 0-68, higher score worse clinical situation)
Neurophysiological cortical changes
Time frame: The day before the first stimulation session and 2 weeks after the first stimulation session
Cortical silent period measured using transcranial magnetic pulse in M1 and simultaneous register of electromyographical response
Neurophysiological cortical changes
Time frame: t2(2 weeks after finishing the protocol)
Cortical silent period measured using transcranial magnetic pulse in M1 and simultaneous register of electromyographical response
3 secondary outcomes
Quality of life changes
Time frame: t2(2 weeks after finishing the protocol)
Encephalographic changes
Time frame: t2(2 weeks after finishing the protocol)
Cognitive changes in objective measures of processing speed
Time frame: t2(2 weeks after finishing the protocol)
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 20 Nov 2020.
- Derived from this study: PubMed 39103947Romero JP, Moreno-Verdu M, Arroyo-Ferrer A, Serrano JI, Herreros-Rodriguez J, Garcia-Caldentey J, Rocon de Lima E, Del Castillo MD. Clinical and neurophysiological effects of bilateral repetitive transcranial magnetic stimulation and EEG-guided neurofeedback in Parkinson's disease: a randomized, four-arm controlled trial. J Neuroeng Rehabil. 2024 Aug 5;21(1):135. doi: 10.1186/s12984-024-01427-5.
- Individual participant dataSharing planned: Yes. Individual anonymized participant data will be available to other researchers under request.
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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.
Juan Pablo Romero Muñoz, MD PhD principal investigator
Universidad Francisco de Vitoria, Facultad de Ciencias Experimentales
Questions about this trial
What is this clinical trial studying?
A study testing Repetitive transcranial magnetic stimulation (rTMS) and EEG guided Neurofeedback (NFB) in people with Parkinson Disease, run by Universidad Francisco de Vitoria.
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 13 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 20 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Motor changes (time frame: The day before the first stimulation session and 2 weeks after the first stimulation session). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04017481, 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 20 Nov 2020.