Neuron DegenerationVIASTIMNCT04605367
Mental Practice (MP) Combined With Transcranial Direct Current Stimulation (tDCS) on Motor Learning in the Elderly
A study testing Transcranial stimulation in people with Neuron Degeneration, run by Hospices Civils de Lyon.
Trial summary
Scientific background and rationale: Motor sequence learning (MSL) is composed of three phases: initial acquisition or rapid learning occurs during the first practice session, characterized by a rapid increase in motor performance; consolidation comes next, in the following hours, with a stabilization or even an… Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuron Degeneration
- What is being tested?
- Transcranial stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Apr 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Male or female
- Aged between 65 and 80.
- Mastery of the French language.
- Available for the entire study.
- Right-handedness of the upper limbs with a score > 0.5 on the Edinburgh laterality test (Oldfield, 1971).
- Right-handedness of the lower limbs with a score of ≥ -6 on the Waterloo laterality test (Waterloo, 1980).
- Cognitively preserved with an MMSE score ≥ 25 (Mini Mental State Examination, GRECO version, 2003).
Who cannot join
- A refusal to participate in the study or to sign the consent.
- No coverage by a Social Security plan.
- A deprivation of civil rights (guardianship, tutorship, protection of justice).
- A Body Mass Index (BMI) > 25kg/m2.
- A nap every afternoon.
- A psychiatric, neurological or motor disorder.
Show all 25Show fewer
- A visuospatial empan < 3 on the Corsi block test (Corsi, 1972).
- A depression score > 5 on the Yesavage Geriatric Depression Scale (Yesavage et al., 1982).
- A walking aid (cane, walker).
- A fall during the last 12 months.
- A risk of falling, with a score > 14s on the Timed Up and GO (TUG, Podsiadlo \& Richardson, 1991).
- A difficulty in standing or moving, grasping or manipulating objects.
- A disabling pain in the upper and/or lower limbs.
- The presence of osteoarthritis or arthritis in the fingers of the left hand and lower limbs.
- A chronic disease (rheumatoid arthritis, fibromyalgia, multiple sclerosis...).
- An injury to the left hand and/or lower limbs that is less than 3 months old.
- A surgery on a joint that is less than 6 months old.
- Current or past practice of an activity involving strong manual dexterity (piano, guitar, typing, etc.) or coordination of the lower limbs (dance, rhythmic gymnastics, English boxing, etc.) for more than 3 hours per week.
- An inability to perform motor imagery with a score of 10 on the Kinesthetic and Visual Imagery Questionnaire (KVIQ, Malouin et al., 2007) as well as an imagined time/actual execution time ratio > 1.5s on the mental chronometric test.
- Common exclusion criteria applied for the safe use of tDCS:
- No significant neurological history (e.g., history of migraines, traumatic brain injury resulting in a loss of consciousness, epilepsy or history of epilepsy);
- No history of alcohol and/or substance abuse;
- No psychiatric illness;
- No metallic implants (intracranial electrodes, surgical clips, pacemaker)
- No wound scalp or skin condition (psoriasis, eczema).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Motor Imagery Combined With Anodal Transcranial Direct Current Stimulation on Complex Motor Sequence Learning in Healthy Older Adults
Scientific background and rationale: Motor sequence learning (MSL) is composed of three phases: initial acquisition or rapid learning occurs during the first practice session, characterized by a rapid increase in motor performance; consolidation comes next, in the following hours, with a stabilization or even an increase in performance without additional practice; finally, slow learning allows long-term memorization of the skills acquired after several practice sessions. Motor sequence learning is an essential ability at any age but is altered with aging. Furthermore, the repetition of movements required for MSL may be tiring for the most vulnerable individuals. There is thus a need to develop the use of alternative and effective methods of MSL in the elderly. Mental practice (MP) based on motor imagery (MI) and anodal transcranial direct current stimulation (a-tDCS) are such innovative methods that have shown a positive impact on MSL in older adults. On the one hand, motor imagery training relates to mentally practicing movements without actual execution. This method has been shown to advantageously complement or even replace physical practice. Nevertheless, for fine and gross motor skills, the association MP/physical practice (PP) has been little studied in healthy elderly subjects. On the other hand, tDCS is a safe and noninvasive brain stimulation method used to modulate cortical excitability and enhance neuroplasticity. It has been shown that an anodal stimulation of the primary motor cortex (M1) immediately after the acquisition of a sequence of finger movements (manual task) enhanced consolidation in healthy elderly people. These effects have, however, never been tested for more ecological sequential tasks involving the whole body (body task).
Aim: The main aim of this study is to investigate the effects of a-tDCS on the consolidation of complex manual and body tasks, after MP alone, PP alone, and MP + PP in older adults.
Read more
A secondary aim is to test the effects of MP alone, PP alone and MP + PP in the acquisition of these complex manual and body tasks, in older adults.
A third aim is to test the evolution of electroencephalographic (EEG) activity between rest and motor imagery of these tasks, and, for motor imagery, before and after training.
- Conditions
- Neuron Degeneration
- Being tested
- Transcranial stimulation
- Keywords
- Motor Imagery, a-tDCS, Neuroaging, Motor Learning
- Medical subject headings
- Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial stimulationDevice
For both tasks, the training modalities are the same. After the pre-test, this group will physically repeat the correct sequence as many times as possible, during 12 blocks of 30s. After this training, they will perform the post-test. And immediately after the post-test, they will receive the real anodal stimulation. The intensity of the current will gradually increase for 30s until it reaches 1mA, will remain constant for 15min, then will gradually decrease for 30s until 0mA is reached. The current density during stimulation will be 0.04 mA/cm². For the manual task the anode will be centered above C4 (according to the international 10-20 EEG system) that is located near the hand area of M1. The cathode will be placed on the supraorbital region ipsilateral to the trained hand (Fp1). For the body task, the anode will be placed in the center of the cortex (Cz) and the cathode will be placed at the medial supraorbital region (Fpz).
| Study group | Role | What they receive |
|---|---|---|
| 100% PP, a-TDCS | Experimental | After the pre-test:
repetition of the correct sequence as many times as possible (12 blocks of 30s).
After the post-test:
Anodal stimulation (intensity : gradual increase for 30s until 1mA, will remain constant for 15min, gradual decrease for 30s until 0mA ;current density : 0.04 mA/cm². Receives: Device: Transcranial stimulation |
| 100% PP, sham TDCS | Experimental | After the pre-test :
physical repetition of the correct sequence as many times as possible, during 12 blocks of 30s.
After the post-test : sham stimulation (gradual increase in current for 30 seconds until 1mA, immediately followed by a gradual decrease for 30 s until 0mA. Receives: Device: Transcranial stimulation |
| 100% MP, a-TDCS | Experimental | After the pre-test :
mental repetition of the correct sequence as many times as possible, during 12 blocks of 30s.
After the post-test:
Anodal stimulation (intensity : gradual increase for 30s until 1mA, will remain constant for 15min, gradual decrease for 30s until 0mA ;current density : 0.04 mA/cm².) Receives: Device: Transcranial stimulation |
| 100% MP, sham TDCS | Experimental | After the pre-test :
mental repetition of the correct sequence as many times as possible, during 12 blocks of 30s.
After the post-test : sham stimulation (gradual increase in current for 30 seconds until 1mA, immediately followed by a gradual decrease for 30 s until 0mA. Receives: Device: Transcranial stimulation |
| 50% MP and 50% PP, a-TDCS | Experimental | After the pre-test :
mental repetition of the correct sequence as many times as possible, during 6 blocks of 30s. Then physical repetition of the correct sequence as many times as possible, during 6 blocks of 30s.
After the post-test : they will receive the real stimulation. Anodal stimulation (intensity : gradual increase for 30s until 1mA, will remain constant for 15min, gradual decrease for 30s until 0mA ;current density : 0.04 mA/cm². Receives: Device: Transcranial stimulation |
| 50% MP and 50% PP, sham TDCS | Experimental | For both tasks, the training modalities are the same. After the pre-test, this group will have to mentally repeat the correct sequence as many times as possible, during 6 blocks of 30s. Then they will have to physically repeat the correct sequence as many times as possible, during 6 blocks of 30s. After this training, they will perform the post-test. And immediately after the post-test, they will receive the sham stimulation. The sham stimulation will be consisted of a gradual increase in current for 30 seconds until 1mA, immediately followed by gradual decrease for 30 s until 0mA. Receives: Device: Transcranial stimulation |
| No practice, No stimulation | No intervention | After the pre-test, this group will read an article for 12 minutes. After this training, they will perform the post-test. Immediately after this, they will read another article during 15 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the number of correct presses or steps to evaluate the consolidation.
A sequential finger tapping task (manual task) and a sequential whole-body task involving leg movements (body task) will be used.
Measured: Immediately after the post-test
Secondary outcomes (8)
Change in the number of correct presses or steps to evaluate the acquisition.
See the primary outcome.
Measured: during the intervention
Change in the number of sequences correctly executed to evaluate the consolidation.
See the primary outcome.
Measured: during the intervention
Change in the number of sequences correctly executed to evaluate the acquisition.
See the primary outcome.
Measured: during the intervention
Change in the power of the Mu and Beta rhythm.
EEG recording will be made for 3 min at rest and during 6 blocks of 30s of MP. EEG recording will be performed using the Starstim 8 (Neuroelectrics, Barcelona, Spain). Starstim is a wireless neurostimulator system allows both the delivery of a tDCS (or sham stimulation) and the recording of EEG activity at 500 Hz. EEG signals will be recorded from 6 Ag/AgCl electrodes. Following the spatial configuration of the international 10-20 system, the electrodes will be placed over the frontal, somatosensory and motor areas: frontocentral (FC2, FC6), central (CZ, C2) and central-parietal (CP2, CP6). After the EEG signal processing, the power of the Mu and Beta rhythm will be extracted.
Measured: baseline and during the intervention
Change in the distance travelled by the center of gravity during the body task.
The trajectory of the pelvis (four markers placed at the anterior and posterior iliac spines) will be recorded with ten infrared cameras (MiqusX, Qualisys, Sweden) and be considered as representing the trajectory of the center of gravity. The data will be transmitted to video analysis software (QTM, Qualisys, Sweden) on a computer.
Measured: This will be done during the 15th day for the body task
Change in the speed of displacement of the center of gravity during the body task.
The trajectory of the pelvis (four markers placed at the anterior and posterior iliac spines) will be recorded with ten infrared cameras (MiqusX, Qualisys, Sweden) and be considered as representing the trajectory of the center of gravity. The data will be transmitted to video analysis software (QTM, Qualisys, Sweden) on a computer.
Measured: This will be done during the 15th day for the body task
Change in the area travelled by the center of gravity during the body task.
The trajectory of the pelvis (four markers placed at the anterior and posterior iliac spines) will be recorded with ten infrared cameras (MiqusX, Qualisys, Sweden) and be considered as representing the trajectory of the center of gravity. The data will be transmitted to video analysis software (QTM, Qualisys, Sweden) on a computer.
Measured: This will be done during the 15th day for the body task
Change in the target's times during the body task.
The trajectory of the pelvis (four markers placed at the anterior and posterior iliac spines) will be recorded with ten infrared cameras (MiqusX, Qualisys, Sweden) and be considered as representing the trajectory of the center of gravity. The data will be transmitted to video analysis software (QTM, Qualisys, Sweden) on a computer.
Measured: This will be done during the 15th day for the body task
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuron DegenerationStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04605367
- Sponsor's protocol ID
- 69HCL20_0204
- Acronym
- VIASTIM
- Status last verified
- Oct 2020
- First submitted
- 15 Oct 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Motor Imagery Combined With Anodal Transcranial Direct Current Stimulation on Complex Motor Sequence Learning in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT04605367
- Acronym / sponsor ID
- VIASTIM / 69HCL20_0204
- Conditions
- Neuron Degeneration
- Keywords
- Motor Imagery, a-tDCS, Neuroaging, Motor Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Apr 2022 (estimated)
- First posted
- 28 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Scientific background and rationale: Motor sequence learning (MSL) is composed of three phases: initial acquisition or rapid learning occurs during the first practice session, characterized by a rapid increase in motor performance; consolidation comes next, in the following hours, with a stabilization or even an increase in performance without additional practice; finally, slow learning allows long-term memorization of the skills acquired after several practice sessions. Motor sequence learning is an essential ability at any age but is altered with aging. Furthermore, the repetition of movements required for MSL may be tiring for the most vulnerable individuals. There is thus a need to develop the use of alternative and effective methods of MSL in the elderly. Mental practice (MP) based on motor imagery (MI) and anodal transcranial direct current stimulation (a-tDCS) are such innovative methods that have shown a positive impact on MSL in older adults. On the one hand, motor imagery training relates to mentally practicing movements without actual execution. This method has been shown to advantageously complement or even replace physical practice. Nevertheless, for fine and gross motor skills, the association MP/physical practice (PP) has been little studied in healthy elderly subjects. On the other hand, tDCS is a safe and noninvasive brain stimulation method used to modulate cortical excitability and enhance neuroplasticity. It has been shown that an anodal stimulation of the primary motor cortex (M1) immediately after the acquisition of a sequence of finger movements (manual task) enhanced consolidation in healthy elderly people. These effects have, however, never been tested for more ecological sequential tasks involving the whole body (body task).
Aim: The main aim of this study is to investigate the effects of a-tDCS on the consolidation of complex manual and body tasks, after MP alone, PP alone, and MP + PP in older adults.
A secondary aim is to test the effects of MP alone, PP alone and MP + PP in the acquisition of these complex manual and body tasks, in older adults.
A third aim is to test the evolution of electroencephalographic (EEG) activity between rest and motor imagery of these tasks, and, for motor imagery, before and after training.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 100% PP, a-TDCS | Experimental | Device: Transcranial stimulationAfter the pre-test: repetition of the correct sequence as many times as possible (12 blocks of 30s). After the post-test: Anodal stimulation (intensity : gradual increase for 30s until 1mA, will remain constant for 15min, gradual decrease for 30s until 0mA ;current density : 0.04 mA/cm². |
| 100% PP, sham TDCS | Experimental | Device: Transcranial stimulationAfter the pre-test : physical repetition of the correct sequence as many times as possible, during 12 blocks of 30s. After the post-test : sham stimulation (gradual increase in current for 30 seconds until 1mA, immediately followed by a gradual decrease for 30 s until 0mA. |
| 100% MP, a-TDCS | Experimental | Device: Transcranial stimulationAfter the pre-test : mental repetition of the correct sequence as many times as possible, during 12 blocks of 30s. After the post-test: Anodal stimulation (intensity : gradual increase for 30s until 1mA, will remain constant for 15min, gradual decrease for 30s until 0mA ;current density : 0.04 mA/cm².) |
| 100% MP, sham TDCS | Experimental | Device: Transcranial stimulationAfter the pre-test : mental repetition of the correct sequence as many times as possible, during 12 blocks of 30s. After the post-test : sham stimulation (gradual increase in current for 30 seconds until 1mA, immediately followed by a gradual decrease for 30 s until 0mA. |
| 50% MP and 50% PP, a-TDCS | Experimental | Device: Transcranial stimulationAfter the pre-test : mental repetition of the correct sequence as many times as possible, during 6 blocks of 30s. Then physical repetition of the correct sequence as many times as possible, during 6 blocks of 30s. After the post-test : they will receive the real stimulation. Anodal stimulation (intensity : gradual increase for 30s until 1mA, will remain constant for 15min, gradual decrease for 30s until 0mA ;current density : 0.04 mA/cm². |
| 50% MP and 50% PP, sham TDCS | Experimental | Device: Transcranial stimulationFor both tasks, the training modalities are the same. After the pre-test, this group will have to mentally repeat the correct sequence as many times as possible, during 6 blocks of 30s. Then they will have to physically repeat the correct sequence as many times as possible, during 6 blocks of 30s. After this training, they will perform the post-test. And immediately after the post-test, they will receive the sham stimulation. The sham stimulation will be consisted of a gradual increase in current for 30 seconds until 1mA, immediately followed by gradual decrease for 30 s until 0mA. |
| No practice, No stimulation | No intervention | –After the pre-test, this group will read an article for 12 minutes. After this training, they will perform the post-test. Immediately after this, they will read another article during 15 minutes. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (7 listed)
- Male or female
- Aged between 65 and 80.
- Mastery of the French language.
- Available for the entire study.
- Right-handedness of the upper limbs with a score > 0.5 on the Edinburgh laterality test (Oldfield, 1971).
Key exclusion criteria (25 listed)
- A refusal to participate in the study or to sign the consent.
- No coverage by a Social Security plan.
- A deprivation of civil rights (guardianship, tutorship, protection of justice).
- A Body Mass Index (BMI) > 25kg/m2.
- A nap every afternoon.
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 stimulationFor both tasks, the training modalities are the same. After the pre-test, this group will physically repeat the correct sequence as many times as possible, during 12 blocks of 30s. After this training, they will perform the post-test. And immediately after the post-test, they will receive the real anodal stimulation. The intensity of the current will gradually increase for 30s until it reaches 1mA, will remain constant for 15min, then will gradually decrease for 30s until 0mA is reached. The current density during stimulation will be 0.04 mA/cm². For the manual task the anode will be centered above C4 (according to the international 10-20 EEG system) that is located near the hand area of M1. The cathode will be placed on the supraorbital region ipsilateral to the trained hand (Fp1). For the body task, the anode will be placed in the center of the cortex (Cz) and the cathode will be placed at the medial supraorbital region (Fpz). | Device | 100% MP, a-TDCS, 100% MP, sham TDCS, 100% PP, a-TDCS, 100% PP, sham TDCS, 50% MP and 50% PP, a-TDCS, 50% MP and 50% PP, sham TDCS |
Primary outcome
Change in the number of correct presses or steps to evaluate the consolidation.
Time frame: Immediately after the post-test
A sequential finger tapping task (manual task) and a sequential whole-body task involving leg movements (body task) will be used.
8 secondary outcomes
Change in the number of correct presses or steps to evaluate the acquisition.
Time frame: during the intervention
Change in the number of sequences correctly executed to evaluate the consolidation.
Time frame: during the intervention
Change in the number of sequences correctly executed to evaluate the acquisition.
Time frame: during the intervention
Change in the power of the Mu and Beta rhythm.
Time frame: baseline and during the intervention
Change in the distance travelled by the center of gravity during the body task.
Time frame: This will be done during the 15th day for the body task
Change in the speed of displacement of the center of gravity during the body task.
Time frame: This will be done during the 15th day for the body task
Change in the area travelled by the center of gravity during the body task.
Time frame: This will be done during the 15th day for the body task
Change in the target's times during the body task.
Time frame: This will be done during the 15th day for the body task
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial stimulation in people with Neuron Degeneration, run by Hospices Civils de Lyon.
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 7 inclusion and 25 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 28 Oct 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pierre Krolak-Salmon, MD-PhD (+33472432050 ext. +33472432054, pierre.krolak-salmon@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the number of correct presses or steps to evaluate the consolidation. (time frame: Immediately after the post-test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Oct 2020.