NCT06729125

Brief Summary

Parkinson's disease (PD) is the second most common neurodegenerative disorder after Alzheimer's disease. It is a progressive and disabling disease with significative impact on quality of life. Since it has no cure, available treatment is targeted to improve the symptoms due to a lack of dopamine in the central nervous system. The aim of the study was to see how transcranial photobiomodulation (tPBM) helped patients with Parkinson's disease.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 11, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

December 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2025

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 3, 2025

Completed
Last Updated

April 8, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

December 5, 2024

Last Update Submit

April 6, 2025

Conditions

Keywords

transcranial photobiomodulation, posture instability, Parkinson's disease, modified Parkinson activity scale, Biodex balance system

Outcome Measures

Primary Outcomes (1)

  • posture stability

    The Biodex Balance System (Biodex Medical Systems Inc, USA) Will be used to assess the limit of stability (overall, forward and backward) pre- and post-treatment.

    8 weeks

Secondary Outcomes (1)

  • functional activity

    8 weeks

Study Arms (2)

study group

EXPERIMENTAL
Device: transcranial photobiomodulation

control group

ACTIVE COMPARATOR
Other: exercises training

Interventions

Single-session transcranial laser stimulation was administered with a continuous-wave, 1,064-nm laser (Model CG-5000 Laser, Cell Gen Therapeutics LLC, Dallas, TX).

study group

balance exercises and others

control group

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • idiopathic PD,
  • Hoehn \& Yahr stage I-IV,
  • independent gait with or without technical assistance
  • stable parkinsonian medication for at least a month before the study star.

You may not qualify if:

  • comorbidities that affect balance or walking,
  • other neurological pathologies besides PD,
  • chronic diseases not medically controlled and participation in another physiotherapy program or sport activity during the intervention period or in the month before starting the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Zaytoonah University

Amaan, Jordan

Location

Related Links

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

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
associate professor hanan hosny M Battesha

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 11, 2024

Study Start

December 15, 2024

Primary Completion

March 20, 2025

Study Completion

April 3, 2025

Last Updated

April 8, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations