- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT06771531
Hjernestimulation for fodsålsfornemmelse hos ældre voksne med somatosensoriske underskud af fodsål (BSFS)
Kortikale mekanismer og modulering af somatosensation hos ældre voksne med fodsål somatosensoriske svækkelser
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Junhong Zhou, PhD
- Telefonnummer: 617-971-5346
- E-mail: junhongzhou@hsl.harvard.edu
Studiesteder
-
-
Massachusetts
-
Roslindale, Massachusetts, Forenede Stater, 02131
- Rekruttering
- Hebrew SeniorLife
-
Kontakt:
- Kathy Tasker
- Telefonnummer: 617-971-5351
- E-mail: KathyTasker@hsl.harvard.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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-komparator: 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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
postural sway area when standing with eyes closed on the foam
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postural sway speed when standing with eyes closed on the foam
Tidsramme: 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
Tidsramme: Before and immediately after intervention
|
This metric assesses mobility. |
Before and immediately after intervention
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
BOLD signal intensity within other relevant cortical regions in response to foot sole stimulation
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Pro00044674
- K01AG075180 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
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