Parkinson's Disease and ParkinsonismNCT06247423
High-frequency Alternating Current Stimulation for Tremor in Parkinson's Disease.
A study testing Active group 10kHz in people with Parkinson's Disease and Parkinsonism and Nerve Block, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
The goal of this randomized, double-blind, placebo-controlled, crossover study is to test the effectiveness of 10 kilohertz (kHz) high-frequency transcutaneous stimulation for tremor in people with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Parkinson's Disease and Parkinsonism, Nerve Block, Motor Activity
- What is being tested?
- Active group 10kHz
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteSpain
- Study dates
- 2 Feb 2024to 30 Sep 2024
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have a confirmed diagnosis of Parkinson's Disease (PD) by a neurologist or specialist physician, specifically with tremor as defined by the consensual declaration of the "Movement Disorder Society".
- Must possess adequate cognitive capacity to perform the tests and understand all the procedure.
- Tolerance to the application of electrotherapy.
Who cannot join
- Treatment for tremor suppression (deep brain stimulation or medication within 5 hours).
- Altered sensitivity in the intervention area
- Recent traumatism or surgeries which interfere with the measures
- Presence of pacemakers or other implanted electrical devices
- Tattoos or other external agents in the treatment area
- Comorbidities or conditions affecting tremor or coordination (cerebellar injury)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of 10kHz High-frequency Alternating Current Transcutaneous Stimulation on Tremor in People With Parkinson's Disease
The goal of this randomized, double-blind, placebo-controlled, crossover study is to test the effectiveness of 10 kilohertz (kHz) high-frequency transcutaneous stimulation for tremor in people with Parkinson's disease. The main questions it aims to answer are:
- Compare the effectiveness between sham stimulation and real stimulation (10kHz) for different types of tremors [rest tremor, postural tremor, kinetic tremor], fine motor skills, and maximal isometric handgrip strength.
- Register adverse events, the blinding success of participants and evaluator, and subjective perception of tremor improvement.
Read more
Participants will perform the following tasks in an "off" state (without levodopa and dopamine agonists medication). All of them were performed on the upper limb with more tremor.
- Rest Tremor: Forearm on the armrest, count backward from 100 to 0 as fast as possible for 1 minute and 30 seconds.
- Postural Tremor: Extend the arm parallel to the floor (90º shoulder flexion with the forearm extended) for 30 seconds.
- Kinetic Tremor: Hold a cup by the handle, raise it close to the mouth for 3 seconds, then return to the initial position.
- Fine Motor Skills: Complete the nine-hole peg test, placing pegs into holes as quickly as possible.
- Handgrip Strength: Squeeze the device as strongly as possible for 3 seconds, then rest for 15 seconds.
Read the detailed description
High-frequency alternating current (HFAC) stimulation involves applying electrical stimulation with a frequency above 1 kilohertz (kHz) to peripheral nerves, inducing immediate, reversible nerve block without causing damage. Studies have shown that frequencies between 10 and 20 kHz reduce maximal isometric grip strength when applied transcutaneously over peripheral nerves, suggesting a partial block of A-alpha fibers, which may help reduce nerve hyperexcitability and motor activity. Tremor-related pathologies, influenced by abnormal muscle activity, significantly impact the quality of life of patients, particularly those with Parkinson's disease (PD), where tremor represents one of the most annoying and disabling symptoms since early stages of the disease.
For these reasons, tremor-related pathologies could benefit from HFAC stimulation. To our knowledge, no studies have applied HFAC stimulation in patients with PD. The main objective of this study is to compare the effectiveness of sham stimulation and real stimulation (10kHz) for tremor [rest tremor, postural tremor, kinetic tremor] in people with PD. Secondary objectives include analyzing the effectiveness of stimulation for fine motor skills and maximal isometric grip strength in people with PD, as well as documenting adverse events and evaluating blinding success.
A double-blind, randomized, crossover-design study will be conducted at the University of Castilla-La Mancha. Two interventions will be performed in people with Parkinson's Disease during "Off" state, randomizing the order: Intervention A: 10kHz stimulation; Intervention B: sham electrical stimulation.
- Being tested
- Active group 10kHz, Sham intervention
- Keywords
- High-frequency alternating current stimulation, Parkinson's Disease, Tremor, Motor activity
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Motor Activity, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active group 10kHzDevice
For electrical stimulation in the active groups, unmodulated alternating currents with a symmetrical rectangular waveform of 10 kHz will be applied for 20 minutes. The current intensity shall be adjusted individually for each participant by increasing the current intensity until the participant reports a "strong but comfortable tingling" sensation just below the motor threshold. One electrode will be placed over the median and radial nerves, while the other over the radial nerve.
The intensity of the current shall be adjusted every two minutes if the tingling sensation decreases. This protocol had been used in previous studies conducted by our research group.
Sham interventionDevice
Sham electrical stimulation will be performed with the same equipment, time, and electrodes as in the active groups without the participants and the evaluator having a view of the device screen. The intensity of the current will be increased for 30 seconds until the sensory threshold ("strong but comfortable tingling sensation") will be reached and after that, the intensity will be reduced to 0 milliamperes (mA) with 30 seconds ramp down. Participants will not receive electrical current during the rest of the placebo intervention. This protocol was used in other studies with similar interventions to blind participants.
| Study group | Role | What they receive |
|---|---|---|
| 10kHz | Experimental | Alternating current stimulation with a 10kHz frequency with a transcutaneous approach, 20 minutes for each intervention. Receives: Device: Active group 10kHz |
| Sham stimulation | Sham comparator | Sham stimulation via transcutaneous approach will be delivered only for the first 30 seconds, following the same procedures as the 10kHz group. Receives: Device: Sham intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resting tremor
The tremor activity will be recorded using surface electromyography, linear and angular accelerations with the "Trigno® Wireless Biofeedback System (SP-W06-017 Delsys Inc. Massachusetts, USA)" device, placing one recording sensors on the muscle surface of the extensor digitorum communis and another on the abductor pollicis brevis muscles. All the tests will be measured with the more tremor-affected hand.
Specifically, for resting tremor the patient will be at rest with their forearms supported, the wrist free, and the elbow flexed at 90 degrees for 1 minute and 30 seconds, while counting backward from 100 to 0 as quickly as possible. Only the last 30 seconds will be registered.
Measured: Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).
Postural tremor
This outcome will be recorded using the "Trigno® Wireless Biofeedback System".
For postural tremor, patients will maintain a posture with flexed shoulders at 90 degrees, extended and pronated forearms, with the wrist in a neutral flexion-extension position for 30 seconds.
Measured: Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).
Kinetic tremor
This outcome will be recorded using the "Trigno® Wireless Biofeedback System".
For kinetic tremor, patients will be asked to grasp a cup by the handle, always placed at the same distance on the table, bring it to their mouth, hold it in that position for 3 seconds, and then return it to its initial position. The test will be performed with the more tremor-affected hand.
Measured: Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).
Secondary outcomes (5)
Fine motor skills-finger dexterity
The fine motor skills will be measured using the "Nine-hole peg test", which is a quantitative and standardized test to measure upper limb function. It involves placing 9 plastic pegs located in a container onto a structure with 9 vertical slots on a table. The test will be performed with the more tremor-affected hand. It won't be allowed to grasp/remove multiple pegs simultaneously. Moreover, the time will start when the subject touches the first peg and ends when the last peg touches the container, and the total time will be recorded in seconds. Additionally, the variable of start time will be added, which measures the time from when the instruction will be given until the subject will reach the first peg.
Measured: Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).
Maximal isometric grip strength
The maximum isometric grip strength will be measured using a hand grip dynamometer (Grip Strength "T.K.K. 5401 GRIP-D, Takei Scientific Instruments CO., LTD., Shinagawa-ku, Tokyo"). The patient's position will be the same as during the measurement of resting tremor, with the dynamometer held by the evaluator.
The force will be sustained for 3 seconds in 3 pain-free trials, with 15-20 seconds of rest between each trial. The final force measurement will be the average of the 3 trials.
Measured: Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).
Blinding success
The success of participant and evaluator blinding will be assessed after the intervention. For this purpose, they will be asked the following question: "What type of treatment do you believe you or the participant received?" with five response options: 1) "I strongly believe that I/he/she received an experimental treatment"; 2) "I somewhat believe that I/he/she received an experimental treatment"; 3) "I strongly believe that I/he/she received a placebo"; 4) "I somewhat believe that I/he/she received a placebo"; 5) "I don't know, I do not answer."
The blinding of subjects and researchers will be assessed using the James' and Bang's blinding indexes.
Measured: 10 minutes after the end of the stimulation [at 30 minutes] (T3).
Adverse events
Adverse effects caused by the current in both interventions will be collected using a questionnaire format. This includes items with "Yes/No" response options to assess tingling, numbness, stiffness, heat, heaviness, tightness/contraction, weakness, pain (burning, stabbing, electric, superficial, deep), or other sensations in the hand and intervention area, including skin alterations under the electrodes. The perceived unpleasantness level during the intervention will be also evaluated using a numeric pain rating scale, where 0 corresponded to "none" and 10 to "the maximum possible".
Measured: 10 minutes after the end of the stimulation [at 30 minutes] (T3) and 24 hours after the stimulation (T4).
Subjective degree of improvement
To assess the patient's subjective degree of improvement, the Patient Global Impression of Improvement (PGI-I) scale will be used after each intervention. This scale will be utilized to evaluate improvement following treatment using a Likert format ranging from 1 to 7, with 1 being "very much improved" and 7 being "very much worse".
Measured: 10 minutes after the end of the stimulation [at 30 minutes] (T3).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start2 Feb 2024
- Primary completion28 Jun 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson's Disease and ParkinsonismStudies 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
- Crossover
- Model description
- Two interventions will be performed: * Intervention A: active stimulation (High-frequency current stimulation 10kHz). * Intervention B: sham stimulation (simulated electrical stimulation).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain, Asociación Parkinson Toledo (CAP Toledo)
- Responsible party
- Sponsor
- Investigators
- Julio Gómez-Soriano, PhD, Principal investigator, Toledo Physiotherapy Research Group (GIFTO). Castilla la Mancha University.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06247423
- Sponsor's protocol ID
- Parkinson-neuromodest-gifto
- Other IDs
- MCIN/10.13039/501100011033
- Status last verified
- Nov 2024
- First submitted
- 22 Jan 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arruda BS, Reis C, Sermon JJ, Pogosyan A, Brown P, Cagnan H. Identifying and modulating distinct tremor states through peripheral nerve stimulation in Parkinsonian rest tremor. J Neuroeng Rehabil. 2021 Dec 25;18(1):179. doi: 10.1186/s12984-021-00973-6.
PubMed 34953492Pascual-Valdunciel A, Hoo GW, Avrillon S, Barroso FO, Goldman JG, Hernandez-Pavon JC, Pons JL. Peripheral electrical stimulation to reduce pathological tremor: a review. J Neuroeng Rehabil. 2021 Feb 15;18(1):33. doi: 10.1186/s12984-021-00811-9.
PubMed 33588841Jitkritsadakul O, Thanawattano C, Anan C, Bhidayasiri R. Tremor's glove-an innovative electrical muscle stimulation therapy for intractable tremor in Parkinson's disease: A randomized sham-controlled trial. J Neurol Sci. 2017 Oct 15;381:331-340. doi: 10.1016/j.jns.2017.08.3246. Epub 2017 Aug 24.
PubMed 28991711
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 10kHz High-frequency Alternating Current Transcutaneous Stimulation on Tremor in People With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06247423
- Acronym / sponsor ID
- Parkinson-neuromodest-gifto
- Keywords
- High-frequency alternating current stimulation, Parkinson's Disease, Tremor, Motor activity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Collaborators
- Ministry of Science and Innovation, Spain, Asociación Parkinson Toledo (CAP Toledo)
- Study start
- 2 Feb 2024 (actual)
- Primary completion
- 28 Jun 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 7 Feb 2024 (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.
The goal of this randomized, double-blind, placebo-controlled, crossover study is to test the effectiveness of 10 kilohertz (kHz) high-frequency transcutaneous stimulation for tremor in people with Parkinson's disease. The main questions it aims to answer are:
- Compare the effectiveness between sham stimulation and real stimulation (10kHz) for different types of tremors [rest tremor, postural tremor, kinetic tremor], fine motor skills, and maximal isometric handgrip strength.
- Register adverse events, the blinding success of participants and evaluator, and subjective perception of tremor improvement.
Participants will perform the following tasks in an "off" state (without levodopa and dopamine agonists medication). All of them were performed on the upper limb with more tremor.
- Rest Tremor: Forearm on the armrest, count backward from 100 to 0 as fast as possible for 1 minute and 30 seconds.
- Postural Tremor: Extend the arm parallel to the floor (90º shoulder flexion with the forearm extended) for 30 seconds.
- Kinetic Tremor: Hold a cup by the handle, raise it close to the mouth for 3 seconds, then return to the initial position.
- Fine Motor Skills: Complete the nine-hole peg test, placing pegs into holes as quickly as possible.
- Handgrip Strength: Squeeze the device as strongly as possible for 3 seconds, then rest for 15 seconds.
Detailed description
High-frequency alternating current (HFAC) stimulation involves applying electrical stimulation with a frequency above 1 kilohertz (kHz) to peripheral nerves, inducing immediate, reversible nerve block without causing damage. Studies have shown that frequencies between 10 and 20 kHz reduce maximal isometric grip strength when applied transcutaneously over peripheral nerves, suggesting a partial block of A-alpha fibers, which may help reduce nerve hyperexcitability and motor activity. Tremor-related pathologies, influenced by abnormal muscle activity, significantly impact the quality of life of patients, particularly those with Parkinson's disease (PD), where tremor represents one of the most annoying and disabling symptoms since early stages of the disease.
For these reasons, tremor-related pathologies could benefit from HFAC stimulation. To our knowledge, no studies have applied HFAC stimulation in patients with PD. The main objective of this study is to compare the effectiveness of sham stimulation and real stimulation (10kHz) for tremor [rest tremor, postural tremor, kinetic tremor] in people with PD. Secondary objectives include analyzing the effectiveness of stimulation for fine motor skills and maximal isometric grip strength in people with PD, as well as documenting adverse events and evaluating blinding success.
A double-blind, randomized, crossover-design study will be conducted at the University of Castilla-La Mancha. Two interventions will be performed in people with Parkinson's Disease during "Off" state, randomizing the order: Intervention A: 10kHz stimulation; Intervention B: sham electrical stimulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Two interventions will be performed: * Intervention A: active stimulation (High-frequency current stimulation 10kHz). * Intervention B: sham stimulation (simulated electrical stimulation).
| Arm | Type | Receives |
|---|---|---|
| 10kHz | Experimental | Device: Active group 10kHzAlternating current stimulation with a 10kHz frequency with a transcutaneous approach, 20 minutes for each intervention. |
| Sham stimulation | Sham comparator | Device: Sham interventionSham stimulation via transcutaneous approach will be delivered only for the first 30 seconds, following the same procedures as the 10kHz group. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have a confirmed diagnosis of Parkinson's Disease (PD) by a neurologist or specialist physician, specifically with tremor as defined by the consensual declaration of the "Movement Disorder Society".
- Must possess adequate cognitive capacity to perform the tests and understand all the procedure.
- Tolerance to the application of electrotherapy.
Key exclusion criteria (6 listed)
- Treatment for tremor suppression (deep brain stimulation or medication within 5 hours).
- Altered sensitivity in the intervention area
- Recent traumatism or surgeries which interfere with the measures
- Presence of pacemakers or other implanted electrical devices
- Tattoos or other external agents in the treatment area
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 |
|---|---|---|
| Active group 10kHzFor electrical stimulation in the active groups, unmodulated alternating currents with a symmetrical rectangular waveform of 10 kHz will be applied for 20 minutes. The current intensity shall be adjusted individually for each participant by increasing the current intensity until the participant reports a "strong but comfortable tingling" sensation just below the motor threshold. One electrode will be placed over the median and radial nerves, while the other over the radial nerve. The intensity of the current shall be adjusted every two minutes if the tingling sensation decreases. This protocol had been used in previous studies conducted by our research group. | Device | 10kHz |
| Sham interventionSham electrical stimulation will be performed with the same equipment, time, and electrodes as in the active groups without the participants and the evaluator having a view of the device screen. The intensity of the current will be increased for 30 seconds until the sensory threshold ("strong but comfortable tingling sensation") will be reached and after that, the intensity will be reduced to 0 milliamperes (mA) with 30 seconds ramp down. Participants will not receive electrical current during the rest of the placebo intervention. This protocol was used in other studies with similar interventions to blind participants. | Device | Sham stimulation |
Primary outcome
Resting tremor
Time frame: Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).
The tremor activity will be recorded using surface electromyography, linear and angular accelerations with the "Trigno® Wireless Biofeedback System (SP-W06-017 Delsys Inc. Massachusetts, USA)" device, placing one recording sensors on the muscle surface of the extensor digitorum communis and another on the abductor pollicis brevis muscles. All the tests will be measured with the more tremor-affected hand. Specifically, for resting tremor the patient will be at rest with their forearms supported, the wrist free, and the elbow flexed at 90 degrees for 1 minute and 30 seconds, while counting backward from 100 to 0 as quickly as possible. Only the last 30 seconds will be registered.
Postural tremor
Time frame: Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).
This outcome will be recorded using the "Trigno® Wireless Biofeedback System". For postural tremor, patients will maintain a posture with flexed shoulders at 90 degrees, extended and pronated forearms, with the wrist in a neutral flexion-extension position for 30 seconds.
Kinetic tremor
Time frame: Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).
This outcome will be recorded using the "Trigno® Wireless Biofeedback System". For kinetic tremor, patients will be asked to grasp a cup by the handle, always placed at the same distance on the table, bring it to their mouth, hold it in that position for 3 seconds, and then return it to its initial position. The test will be performed with the more tremor-affected hand.
5 secondary outcomes
Fine motor skills-finger dexterity
Time frame: Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).
Maximal isometric grip strength
Time frame: Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).
Blinding success
Time frame: 10 minutes after the end of the stimulation [at 30 minutes] (T3).
Adverse events
Time frame: 10 minutes after the end of the stimulation [at 30 minutes] (T3) and 24 hours after the stimulation (T4).
Subjective degree of improvement
Time frame: 10 minutes after the end of the stimulation [at 30 minutes] (T3).
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 8 Nov 2024.
- Background: PubMed 34953492Arruda BS, Reis C, Sermon JJ, Pogosyan A, Brown P, Cagnan H. Identifying and modulating distinct tremor states through peripheral nerve stimulation in Parkinsonian rest tremor. J Neuroeng Rehabil. 2021 Dec 25;18(1):179. doi: 10.1186/s12984-021-00973-6.
- Background: PubMed 33588841Pascual-Valdunciel A, Hoo GW, Avrillon S, Barroso FO, Goldman JG, Hernandez-Pavon JC, Pons JL. Peripheral electrical stimulation to reduce pathological tremor: a review. J Neuroeng Rehabil. 2021 Feb 15;18(1):33. doi: 10.1186/s12984-021-00811-9.
- Results publication: PubMed 28991711Jitkritsadakul O, Thanawattano C, Anan C, Bhidayasiri R. Tremor's glove-an innovative electrical muscle stimulation therapy for intractable tremor in Parkinson's disease: A randomized sham-controlled trial. J Neurol Sci. 2017 Oct 15;381:331-340. doi: 10.1016/j.jns.2017.08.3246. Epub 2017 Aug 24.
- We used the references explained on this page to place the electromyography sensors.Link provided by the sponsor.
- 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.
Julio Gómez-Soriano, PhD principal investigator
Toledo Physiotherapy Research Group (GIFTO). Castilla la Mancha University.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active group 10kHz in people with Parkinson's Disease and Parkinsonism and Nerve Block, run by University of Castilla-La Mancha at 1 site in Spain.
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 3 inclusion and 6 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 8 Nov 2024. 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 Spain. 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?
Resting tremor (time frame: Before stimulation (T0), during stimulation [at 10 minutes] (T1), immediately after the end of the stimulation [at 20 minutes] (T2), and 10 minutes after the end of the stimulation [at 30 minutes] (T3).). The study lists 3 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 NCT06247423, which also lists 3 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 8 Nov 2024.