Can Photobiomodulation Improve Balance and Cognition in Individuals Over 60: a Pilot Feasibility Placebo Randomized Controlled Trial.

NCT07260903 | Recruiting

• 1 other identifier: PMB balance and cognition
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

As people age, changes in balance and memory can make daily life more difficult and increase the risk of falls. Falls are one of the main causes of injury, hospitalization and loss of independence in older adults, while even mild declines in memory and concentration can reduce confidence, social participation and overall quality of life. Therefore, safe, affordable, and practical ways to help older adults remain steady on their feet and mentally sharp are urgently needed. The aim of this project is therefore to conduct a pilot feasibility randomized controlled trial to examine whether regular home-based photobiomodulation can improve balance and cognitive function in adults aged over 60. If successful, this research could help shape future strategies for preventing falls, enhancing wellbeing and maintaining independence in older people.

Conditions

Age >60

Outcome Measures

Primary Outcomes (3)

• n-1-back (deviation)

  The n-1-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-1 trials earlier.

  Baseline

• n-1-back (deviation)

  The n-1-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-1 trials earlier.

  1 hour

• n-1-back (deviation)

  The n-1-back (deviation) task is a working memory test where participants respond when the current stimulus differs from the one presented n-1 trials earlier.

  8-weeks

Secondary Outcomes (51)

• n-2-back (deviation)

  Baseline

• n-2-back (deviation)

  1 hour

• n-2-back (deviation)

  8-weeks

• n-1-back (post-deviation)

  Baseline

• n-1-back (post-deviation)

  1 hour

Study Arms (2)

Sham photobiomodulation

SHAM COMPARATOR

8-weeks sham photobiomodulation. The sham device will follow the same protocol but without active light emission.

Other: Sham 8-weeks photobiomodulation

Photobiomodulation

EXPERIMENTAL

8-weeks photobiomodulation Twenty-four-minute photobiomodulation stimulation (twelve minutes at 670 nm followed by twelve minutes at 810 nm). Three times per week for 8-weeks.

Device: Photobiomodulation

Interventions

Sham 8-weeks photobiomodulation OTHER

The sham device will follow the same protocol but without active light emission.

Sham photobiomodulation

Photobiomodulation DEVICE

8-weeks photobiomodulation

Photobiomodulation

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged from 60-80 years
• Ability to complete written questionnaires independently
• Able to provide informed consent

You may not qualify if:

• Current or past history of head injury
• Use of medications acting on the central nervous system
• Active skin conditions on the forehead or scalp
• Ongoing brain stimulation therapy
• History of migraines
• Sensitive skin, allergies

Sponsors & Collaborators

• University of Central Lancashire: lead

Study Sites (1)

University of Central Lancashire

Preston, Lancashire, PR4 0PE, United Kingdom

RECRUITING

MeSH Terms

Interventions

Low-Level Light Therapy; salicylhydroxamic acid

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Central Study Contacts

Jonathan Sinclair, DSc

CONTACT

07875651533; jksinclair@lancashire.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 3, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): July 10, 2027
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)