Mental Practice (MP) Combined With Transcranial Direct Current Stimulation (tDCS) on Motor Learning in the Elderly

NCT04605367 | Unknown

• 1 other identifier: 69HCL20_0204
• Study Type: interventional
• Target: 105
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Neuron Degeneration

Keywords

Motor Imagery; a-tDCS; Neuroaging; Motor Learning

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after the post-test

Secondary Outcomes (8)

• Change in the number of correct presses or steps to evaluate the acquisition.

  during the intervention

• Change in the number of sequences correctly executed to evaluate the consolidation.

  during the intervention

• Change in the number of sequences correctly executed to evaluate the acquisition.

  during the intervention

• Change in the power of the Mu and Beta rhythm.

  baseline and during the intervention

• Change in the distance travelled by the center of gravity during the body task.

  This will be done during the 15th day for the body task

Study Arms (7)

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.

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.

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.)

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.

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.

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.

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.

Interventions

Transcranial stimulation DEVICE

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).

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

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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...).

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

MeSH Terms

Conditions

Nerve Degeneration

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Pierre Krolak-Salmon, MD-PhD

CONTACT

+33472432050; pierre.krolak-salmon@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: This is a double-blind study for the tDCS part. Participant will be blind to the type of stimulation (sham or real tDCS). The experimenter will be also blind to the type of stimulation using the "study mode" implemented in the stimulator device that encodes sham and real stimulation mode using predefined numeric codes.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: October 28, 2020
• Study Start: November 1, 2020
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: October 28, 2020

Record last verified: 2020-10