Parkinson DiseaseNCT05264909
Assessment of Transcranial Electrical Stimulation and Auditory Stimulation During Walking in Parkinson Patients
A study testing Multi-channel Transcranial direct current stimulation in people with Parkinson Disease, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.
Trial summary
Parkinson's disease affects 1 in 100 people over the age of 60. Parkinson's disease (PD) is a progressive disease of the nervous system that affects movement, produced by the destruction of dopaminergic neurons found in a region of the brain called the basal ganglia Over time, different strategies have been developed… Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Multi-channel Transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChile
- Study dates
- 1 Aug 2021to 31 Dec 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson Disease
- Both gender
- Informed consent accepted
- Adults
Who cannot join
- Mental diseases
- Injuries in the scalp skin
- Inflammatory tegumentary diseases
- Migraines
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Chile1 site, 1 recruiting
- Recruiting
Corporación de Rehabilitación Club de Leones Cruz del Sur
Punta Arenas, Region of Magallanes, 6211525
Patricio E Barria Aburto, MSc. Eng, +560612202200, pbarria@rehabilitamos.org
Andre I Moris, Eng., +560612202200, laboratorios@rehabilitamos.org
About this study
Parkinson's disease affects 1 in 100 people over the age of 60. Parkinson's disease (PD) is a progressive disease of the nervous system that affects movement, produced by the destruction of dopaminergic neurons found in a region of the brain called the basal ganglia Over time, different strategies have been developed to treat and slow the progress of the disease, including pharmacological, rehabilitative and even surgical treatments.
Transcranial direct current stimulation (tDCS) is a brain stimulation technique that delivers a low-intensity electrical current to the scalp, usually between 1 and 2 mA over approximately 5 to 30 minutes. The tDCS technique is used with the aim of enhancing a specific brain activity through the neuromodulation of neuronal excitability. In pathologies such as PD, these therapies have been shown to induce immediate after-effects in the brain that translate into reduced gait freezing and improvements in executive function and mobility. In addition, the combined effects of tDCS and physical therapy on the walking ability of PD patients have been studied, where it was shown that anodic tDCS and physiotherapy could be used as a combination treatment to improve patients' gait speed.
Read more
Another potential therapeutic tool in the treatment of PD consists of the use of sound stimulation with beat frequencies similar to the step. Specifically, this technology is characterized by presenting two tones of different frequencies for each ear in order to influence the mood and mental performance of the listener.
This protocol is proposed in order to evaluate the effect of tDCS combined with auditory and binaural stimulus strategies during gait therapy in patients with Parkinson's disease.
Read the detailed description
According to the World Health Organization (WHO), Parkinson's disease affects 1 in 100 people over the age of 60. Currently, there are about 7 million people with this disease in the world and the WHO predicts that by 2030 they will reach more than 12 million.
Parkinson's disease (PD) is a progressive disease of the nervous system that affects movement, produced by the destruction of dopaminergic neurons found in a region of the brain called the basal ganglia. This disease usually affects people over 60 years of age, whose symptoms worsen as the disease progresses and in many cases the ability to function in everyday situations is greatly affected. Due to decreased levels of dopamine, motor symptoms such as tremor, stiffness, slowness of movement, postural instability and other non-motor symptoms such as depression, hallucinations, insomnia and dysfunction of the autonomous organic systems, for example, digestion and blood pressure, as well as alteration in the expression of emotions. Over time, different strategies have been developed to treat and slow the progress of the disease, including pharmacological, rehabilitative and even surgical treatments.
Transcranial direct current stimulation (tDCS) is a brain stimulation technique that delivers a low-intensity electrical current to the scalp, usually between 1 and 2 mA over approximately 5 to 30 minutes. During tDCS, most people feel a slight tingling, pricking, itching or warmth, however, these sensations are not painful and disappear when the stimulation is stopped. The tDCS technique is used with the aim of enhancing a specific brain activity through the neuromodulation of neuronal excitability. In pathologies such as PD, these therapies have been shown to induce immediate after-effects in the brain that translate into reduced gait freezing and improvements in executive function and mobility. In addition, the combined effects of tDCS and physical therapy on the walking ability of PD patients have been studied, where it was shown that anodic tDCS and physiotherapy could be used as a combination treatment to improve patients' gait speed.
Another potential therapeutic tool in the treatment of PD consists of the use of sound stimulation with beat frequencies similar to the step. Sounds, mainly rhythm, have also been shown to improve gait characteristics (speed, time and cadence of passage) and eliminate frozen gait, characteristic in this type of population. Sound strategies such as Binaural Beats (BBs) improve the ability of upper and lower limb movements in PD patients. Specifically, this technology is characterized by presenting two tones of different frequencies for each ear in order to influence the mood and mental performance of the listener. In accordance with the above, this protocol is proposed in order to evaluate the effect of tDCS combined with auditory and binaural stimulus strategies during gait therapy in patients with Parkinson's disease.
- Conditions
- Parkinson Disease
- Being tested
- Multi-channel Transcranial direct current stimulation
- Keywords
- transcranial direct current stimulation, auditory stimulation, gait analisys, Parkinson Disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-channel Transcranial direct current stimulationDevice
A medical grade tDCS device will be use in this study (Star Stim TES, Neuroelectrics, Spain). The device is a wireless multi-channel transcranial direct current stimulator that incorporates an 8-channel headcap for stimulation through gel electrodes or classic sponge electrodes. The device is integrated with a user interface for the configuration and monitoring of the stimulus parameters and a fast multifocal simulation of the tDCS electric field using an advanced brain model
| Study group | Role | What they receive |
|---|---|---|
| Transcranial Direct Current Stimulation TDCS | Experimental | Each subject will receive transcranial electrical stimulation at primary motor located in Cz based on the EEG 10-20 international system. The program include 18 sessions with a frequency of 3 times per week during 6 weeks. Therefore, during tDCS sessions, subjects will receive stimulation for 15 minutes with a current of 1.5 milliamp using 7x5 cm electrodes.
During the stimulation, the patient must simultaneously perform gait training for 30 minutes where the speed of each step is guided by the frequency of biaural rhythms and beats, constantly heard through hearing aids. Additionally, the length of the passage will be indicated by white stripes (50 cm long and 5 cm wide), placed perpendicular along a walkway of 6.5 m.
Thus, each session will be monitored on safety aspects of the subjects with emphasis on skin problems and other possible side effects of tDCS. Receives: Device: Multi-channel Transcranial direct current stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait Deviation Index Baseline
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system
Measured: Baseline
Gait Deviation Index Post-Intervention
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system
Measured: 8 weeks
Secondary outcomes (2)
Power spectral density in the frequency of motor imagery from primary motor cortex Baseline
continuous signals will be acquired from the primary motor cortex of lower limbs (FcZ, C2, Cz, C1, Cpz) according to the 10-20 International EEG System. Power spectral density in the frequency band of motor imagery (8-32Hz) will be obtained by OpenVibe Software and Matlab. The measure unit is Decibels per Hertz(dB/Hz).
Measured: Baseline
Power spectral density in the frequency of motor imagery from primary motor cortex Post-Intervention
continuous signals will be acquired from the primary motor cortex of lower limbs (FcZ, C2, Cz, C1, Cpz) according to the 10-20 International EEG System. Power spectral density in the frequency band of motor imagery (8-32Hz) will be obtained by OpenVibe Software and Matlab. The measure unit is Decibels per Hertz(dB/Hz).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2022
- Study start1 Aug 2021
- Primary completion1 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Corporación de Rehabilitación Club de Leones Cruz del Sur
- Sponsor type
- University, hospital or other
- Collaborators
- Colombian School of Engineering Julio Garavito, Universidad del Rosario
- Responsible party
- Sponsor
- Investigators
- Patricio E Barría Aburto, MSc., Principal investigator, Corporación de Rehabilitacion Club de Leones Cruz del Sur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05264909
- Sponsor's protocol ID
- CorporacionRCLCS0006
- Status last verified
- Feb 2022
- First submitted
- 22 Feb 2022
- Last updated
- 18 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Areas FZDS, Nakamura-Palacios EM, Boening A, Areas GPT, Nascimento LR. Does neuromodulation transcranial direct current stimulation (tDCS) associated with peripheral stimulation through exercise to walk have an impact on falls in people with Parkinson's disease? Med Hypotheses. 2020 Nov;144:109916. doi: 10.1016/j.mehy.2020.109916. Epub 2020 Jun 4.
PubMed 32526508Dagan M, Herman T, Harrison R, Zhou J, Giladi N, Ruffini G, Manor B, Hausdorff JM. Multitarget transcranial direct current stimulation for freezing of gait in Parkinson's disease. Mov Disord. 2018 Apr;33(4):642-646. doi: 10.1002/mds.27300. Epub 2018 Feb 13.
PubMed 29436740Yotnuengnit P, Bhidayasiri R, Donkhan R, Chaluaysrimuang J, Piravej K. Effects of Transcranial Direct Current Stimulation Plus Physical Therapy on Gait in Patients With Parkinson Disease: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Jan;97(1):7-15. doi: 10.1097/PHM.0000000000000783.
PubMed 28650857Ghai S, Ghai I, Schmitz G, Effenberg AO. Effect of rhythmic auditory cueing on parkinsonian gait: A systematic review and meta-analysis. Sci Rep. 2018 Jan 11;8(1):506. doi: 10.1038/s41598-017-16232-5.
PubMed 29323122Brabenec L, Klobusiakova P, Barton M, Mekyska J, Galaz Z, Zvoncak V, Kiska T, Mucha J, Smekal Z, Kostalova M, Rektorova I. Non-invasive stimulation of the auditory feedback area for improved articulation in Parkinson's disease. Parkinsonism Relat Disord. 2019 Apr;61:187-192. doi: 10.1016/j.parkreldis.2018.10.011. Epub 2018 Oct 10.
PubMed 30337204Galvez G, Recuero M, Canuet L, Del-Pozo F. Short-Term Effects of Binaural Beats on EEG Power, Functional Connectivity, Cognition, Gait and Anxiety in Parkinson's Disease. Int J Neural Syst. 2018 Jun;28(5):1750055. doi: 10.1142/S0129065717500551. Epub 2017 Nov 13.
PubMed 29297265Costa-Ribeiro A, Maux A, Bosford T, Aoki Y, Castro R, Baltar A, Shirahige L, Moura Filho A, Nitsche MA, Monte-Silva K. Transcranial direct current stimulation associated with gait training in Parkinson's disease: A pilot randomized clinical trial. Dev Neurorehabil. 2017 Apr;20(3):121-128. doi: 10.3109/17518423.2015.1131755. Epub 2016 Feb 10.
PubMed 26864140Galli M, Cimolin V, De Pandis MF, Schwartz MH, Albertini G. Use of the Gait Deviation index for the evaluation of patients with Parkinson's disease. J Mot Behav. 2012;44(3):161-7. doi: 10.1080/00222895.2012.664180. Epub 2012 Mar 28.
PubMed 22455905Stuart S, Wagner J, Makeig S, Mancini M. Brain Activity Response to Visual Cues for Gait Impairment in Parkinson's Disease: An EEG Study. Neurorehabil Neural Repair. 2021 Nov;35(11):996-1009. doi: 10.1177/15459683211041317. Epub 2021 Sep 10.
PubMed 34505536
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Transcranial Electrical Stimulation and Auditory Stimulation During Walking in Parkinson Patients
- ClinicalTrials.gov ID
- NCT05264909
- Acronym / sponsor ID
- CorporacionRCLCS0006
- Conditions
- Parkinson Disease
- Keywords
- transcranial direct current stimulation, auditory stimulation, gait analisys, Parkinson Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Corporación de Rehabilitación Club de Leones Cruz del SurUniversity, hospital or other
- Collaborators
- Colombian School of Engineering Julio Garavito, Universidad del Rosario
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 3 Mar 2022 (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.
Parkinson's disease affects 1 in 100 people over the age of 60. Parkinson's disease (PD) is a progressive disease of the nervous system that affects movement, produced by the destruction of dopaminergic neurons found in a region of the brain called the basal ganglia Over time, different strategies have been developed to treat and slow the progress of the disease, including pharmacological, rehabilitative and even surgical treatments.
Transcranial direct current stimulation (tDCS) is a brain stimulation technique that delivers a low-intensity electrical current to the scalp, usually between 1 and 2 mA over approximately 5 to 30 minutes. The tDCS technique is used with the aim of enhancing a specific brain activity through the neuromodulation of neuronal excitability. In pathologies such as PD, these therapies have been shown to induce immediate after-effects in the brain that translate into reduced gait freezing and improvements in executive function and mobility. In addition, the combined effects of tDCS and physical therapy on the walking ability of PD patients have been studied, where it was shown that anodic tDCS and physiotherapy could be used as a combination treatment to improve patients' gait speed.
Another potential therapeutic tool in the treatment of PD consists of the use of sound stimulation with beat frequencies similar to the step. Specifically, this technology is characterized by presenting two tones of different frequencies for each ear in order to influence the mood and mental performance of the listener.
This protocol is proposed in order to evaluate the effect of tDCS combined with auditory and binaural stimulus strategies during gait therapy in patients with Parkinson's disease.
Detailed description
According to the World Health Organization (WHO), Parkinson's disease affects 1 in 100 people over the age of 60. Currently, there are about 7 million people with this disease in the world and the WHO predicts that by 2030 they will reach more than 12 million.
Parkinson's disease (PD) is a progressive disease of the nervous system that affects movement, produced by the destruction of dopaminergic neurons found in a region of the brain called the basal ganglia. This disease usually affects people over 60 years of age, whose symptoms worsen as the disease progresses and in many cases the ability to function in everyday situations is greatly affected. Due to decreased levels of dopamine, motor symptoms such as tremor, stiffness, slowness of movement, postural instability and other non-motor symptoms such as depression, hallucinations, insomnia and dysfunction of the autonomous organic systems, for example, digestion and blood pressure, as well as alteration in the expression of emotions. Over time, different strategies have been developed to treat and slow the progress of the disease, including pharmacological, rehabilitative and even surgical treatments.
Transcranial direct current stimulation (tDCS) is a brain stimulation technique that delivers a low-intensity electrical current to the scalp, usually between 1 and 2 mA over approximately 5 to 30 minutes. During tDCS, most people feel a slight tingling, pricking, itching or warmth, however, these sensations are not painful and disappear when the stimulation is stopped. The tDCS technique is used with the aim of enhancing a specific brain activity through the neuromodulation of neuronal excitability. In pathologies such as PD, these therapies have been shown to induce immediate after-effects in the brain that translate into reduced gait freezing and improvements in executive function and mobility. In addition, the combined effects of tDCS and physical therapy on the walking ability of PD patients have been studied, where it was shown that anodic tDCS and physiotherapy could be used as a combination treatment to improve patients' gait speed.
Another potential therapeutic tool in the treatment of PD consists of the use of sound stimulation with beat frequencies similar to the step. Sounds, mainly rhythm, have also been shown to improve gait characteristics (speed, time and cadence of passage) and eliminate frozen gait, characteristic in this type of population. Sound strategies such as Binaural Beats (BBs) improve the ability of upper and lower limb movements in PD patients. Specifically, this technology is characterized by presenting two tones of different frequencies for each ear in order to influence the mood and mental performance of the listener. In accordance with the above, this protocol is proposed in order to evaluate the effect of tDCS combined with auditory and binaural stimulus strategies during gait therapy in patients with Parkinson's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcranial Direct Current Stimulation TDCS | Experimental | Device: Multi-channel Transcranial direct current stimulationEach subject will receive transcranial electrical stimulation at primary motor located in Cz based on the EEG 10-20 international system. The program include 18 sessions with a frequency of 3 times per week during 6 weeks. Therefore, during tDCS sessions, subjects will receive stimulation for 15 minutes with a current of 1.5 milliamp using 7x5 cm electrodes. During the stimulation, the patient must simultaneously perform gait training for 30 minutes where the speed of each step is guided by the frequency of biaural rhythms and beats, constantly heard through hearing aids. Additionally, the length of the passage will be indicated by white stripes (50 cm long and 5 cm wide), placed perpendicular along a walkway of 6.5 m. Thus, each session will be monitored on safety aspects of the subjects with emphasis on skin problems and other possible side effects of tDCS. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Parkinson Disease
- Both gender
- Informed consent accepted
- Adults
Key exclusion criteria (5 listed)
- Mental diseases
- Injuries in the scalp skin
- Inflammatory tegumentary diseases
- Migraines
- Pregnancy
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 |
|---|---|---|
| Multi-channel Transcranial direct current stimulationA medical grade tDCS device will be use in this study (Star Stim TES, Neuroelectrics, Spain). The device is a wireless multi-channel transcranial direct current stimulator that incorporates an 8-channel headcap for stimulation through gel electrodes or classic sponge electrodes. The device is integrated with a user interface for the configuration and monitoring of the stimulus parameters and a fast multifocal simulation of the tDCS electric field using an advanced brain model | Device | Transcranial Direct Current Stimulation TDCS |
Primary outcome
Gait Deviation Index Baseline
Time frame: Baseline
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system
Gait Deviation Index Post-Intervention
Time frame: 8 weeks
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system
2 secondary outcomes
Power spectral density in the frequency of motor imagery from primary motor cortex Baseline
Time frame: Baseline
Power spectral density in the frequency of motor imagery from primary motor cortex Post-Intervention
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2022.
- Background: PubMed 32526508Areas FZDS, Nakamura-Palacios EM, Boening A, Areas GPT, Nascimento LR. Does neuromodulation transcranial direct current stimulation (tDCS) associated with peripheral stimulation through exercise to walk have an impact on falls in people with Parkinson's disease? Med Hypotheses. 2020 Nov;144:109916. doi: 10.1016/j.mehy.2020.109916. Epub 2020 Jun 4.
- Background: PubMed 29436740Dagan M, Herman T, Harrison R, Zhou J, Giladi N, Ruffini G, Manor B, Hausdorff JM. Multitarget transcranial direct current stimulation for freezing of gait in Parkinson's disease. Mov Disord. 2018 Apr;33(4):642-646. doi: 10.1002/mds.27300. Epub 2018 Feb 13.
- Background: PubMed 28650857Yotnuengnit P, Bhidayasiri R, Donkhan R, Chaluaysrimuang J, Piravej K. Effects of Transcranial Direct Current Stimulation Plus Physical Therapy on Gait in Patients With Parkinson Disease: A Randomized Controlled Trial. Am J Phys Med Rehabil. 2018 Jan;97(1):7-15. doi: 10.1097/PHM.0000000000000783.
- Background: PubMed 29323122Ghai S, Ghai I, Schmitz G, Effenberg AO. Effect of rhythmic auditory cueing on parkinsonian gait: A systematic review and meta-analysis. Sci Rep. 2018 Jan 11;8(1):506. doi: 10.1038/s41598-017-16232-5.
- Background: PubMed 30337204Brabenec L, Klobusiakova P, Barton M, Mekyska J, Galaz Z, Zvoncak V, Kiska T, Mucha J, Smekal Z, Kostalova M, Rektorova I. Non-invasive stimulation of the auditory feedback area for improved articulation in Parkinson's disease. Parkinsonism Relat Disord. 2019 Apr;61:187-192. doi: 10.1016/j.parkreldis.2018.10.011. Epub 2018 Oct 10.
- Background: PubMed 29297265Galvez G, Recuero M, Canuet L, Del-Pozo F. Short-Term Effects of Binaural Beats on EEG Power, Functional Connectivity, Cognition, Gait and Anxiety in Parkinson's Disease. Int J Neural Syst. 2018 Jun;28(5):1750055. doi: 10.1142/S0129065717500551. Epub 2017 Nov 13.
- Background: PubMed 26864140Costa-Ribeiro A, Maux A, Bosford T, Aoki Y, Castro R, Baltar A, Shirahige L, Moura Filho A, Nitsche MA, Monte-Silva K. Transcranial direct current stimulation associated with gait training in Parkinson's disease: A pilot randomized clinical trial. Dev Neurorehabil. 2017 Apr;20(3):121-128. doi: 10.3109/17518423.2015.1131755. Epub 2016 Feb 10.
- Background: PubMed 22455905Galli M, Cimolin V, De Pandis MF, Schwartz MH, Albertini G. Use of the Gait Deviation index for the evaluation of patients with Parkinson's disease. J Mot Behav. 2012;44(3):161-7. doi: 10.1080/00222895.2012.664180. Epub 2012 Mar 28.
- Background: PubMed 34505536Stuart S, Wagner J, Makeig S, Mancini M. Brain Activity Response to Visual Cues for Gait Impairment in Parkinson's Disease: An EEG Study. Neurorehabil Neural Repair. 2021 Nov;35(11):996-1009. doi: 10.1177/15459683211041317. Epub 2021 Sep 10.
- 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.
Patricio E Barría Aburto, MSc. principal investigator
Corporación de Rehabilitacion Club de Leones Cruz del Sur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-channel Transcranial direct current stimulation in people with Parkinson Disease, run by Corporación de Rehabilitación Club de Leones Cruz del Sur at 1 site in Chile.
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 5 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: status not confirmed, as of the sponsor's last update on 18 Mar 2022. 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 Chile. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricio E Barria Aburto, MSc (+569684585709, pbarria@rehabilitamos.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait Deviation Index Baseline (time frame: Baseline). The study lists 2 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 NCT05264909, which also lists 9 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 18 Mar 2022.