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- Klinische proef NCT06771531
Hersenstimulatie voor voetzoolgevoel bij oudere volwassenen met somatosensorische tekorten aan de voetzool (BSFS)
Corticale mechanismen en modulatie van somatosensatie bij oudere volwassenen met somatosensorische stoornissen in de voetzolen
In older adults, diminished sensation of the legs and feet is highly prevalent and causes poor balance and reduced mobility. This type of sensation is not only dependent upon the receptors and nerves in the legs and feet, but also upon a complex central nervous system pathway that includes the cerebral cortex of the brain. This project will use a form of noninvasive brain stimulation called transcranial direct current stimulation (tDCS) to test whether increasing the excitability of the brain networks that process sensory feedback can augment foot sole sensation, balance, and mobility in older adults suffering from mild-to-moderate foot sole sensory impairments.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Junhong Zhou, PhD
- Telefoonnummer: 617-971-5346
- E-mail: junhongzhou@hsl.harvard.edu
Studie Locaties
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Massachusetts
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Roslindale, Massachusetts, Verenigde Staten, 02131
- Werving
- Hebrew SeniorLife
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Contact:
- Kathy Tasker
- Telefoonnummer: 617-971-5351
- E-mail: KathyTasker@hsl.harvard.edu
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Aged ≥65 years.
- Self-reported feeling of unsteadiness or difficulty when standing and walking.
- Mild-to-moderate foot-sole somatosensory impairment: the ability to perceive 75g monofilament but inability to perceive 10g monofilament.
Exclusion Criteria:
- self-reported inability to stand or walk continuously for one minute without personal assistance (canes or walkers allowed);
- history or presence of foot ulceration, amputation, or deformities;
- self-reported uncontrolled pain or pain that is associated with mobility disability;
- uncontrolled diabetes mellitus;
- hospitalization within the past three months due to acute illness, or as the result of a musculoskeletal injury significantly affecting balance;
- persistent severe pain of lower extremity when standing or walking;
- diagnosis of dementia, Parkinson's disease, or stroke that affects balance;
- unstable medical condition;
- legal blindness or deafness;
- uncontrolled hypertension (i.e., systolic BP >180, diastolic BP >100 mm Hg, or prescription of ≥3 anti-hypertensive medications);
- functionally limiting nephropathy, severe diseases or transplant of the kidney or liver, renal or congestive heart failure;
- active cancer treatment;
- balance disorders due to past use of chemotherapy or history of Guillain-Barré syndrome;
- use of neuro-active or recreational drugs (e.g., sedatives, anti-psychotics), or alcohol abuse, which may affect the brain excitability;
- contraindications to MRI or tDCS (e.g., personal or family history of seizures or epilepsy, metallic or electric bio-implants, claustrophobia, brain surgery);
- persistent vertigo;
- history of Charcot-Marie-Tooth nerve disease.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Crossover-opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: tDCS group
Participants in this arm will receive the real tDCS intervention. |
tDCS can safely and selectively modulate cortical excitability (specifically neuronal firing likelihood) by transferring weak electrical currents between scalp electrodes. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA in this study. |
|
Sham-vergelijker: sham group
Participants in this arm will receive the sham stimulation as control. |
sham stimulation will implement the same protocol of the tDCS intervention; however, only very low-level currents (no more than 0.5 mA) are transferred between the same electrodes used for the tDCS throughout the 20-minute session. This strategy effectively mimics the cutaneous sensations and skin redness induced by creating only micro cortical electric fields. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
postural sway area when standing with eyes closed on the foam
Tijdsspanne: Before and immediately after intervention
|
This metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture. |
Before and immediately after intervention
|
|
Timed Up-and-Go (TUG) time
Tijdsspanne: Before and immediately after intervention
|
This metric assesses mobility. |
Before and immediately after intervention
|
|
On-target Blood oxygen level dependent (BOLD) signal intensity in response to foot sole stimulation
Tijdsspanne: Before and immediately after intervention
|
This metric assesses the degree to which brain cortical regions activated by the walking-related foot-sole stimulation. |
Before and immediately after intervention
|
|
Standing vibratory thresholds of each foot sole
Tijdsspanne: Before and immediately after intervention
|
This metric assesses the degree to which the foot soles can sense the vibro-tactile stimuli when standing. |
Before and immediately after intervention
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Postural sway speed when standing with eyes closed on the foam
Tijdsspanne: Before and immediately after intervention
|
This metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture. |
Before and immediately after intervention
|
|
Gait speed of 10m walking test
Tijdsspanne: Before and immediately after intervention
|
This metric assesses mobility. |
Before and immediately after intervention
|
Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
BOLD signal intensity within other relevant cortical regions in response to foot sole stimulation
Tijdsspanne: Before and immediately after intervention
|
This metric assesses the degree to which brain cortical regions activated by the walking-related foot-sole stimulation. |
Before and immediately after intervention
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- Pro00044674
- K01AG075180 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
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