Investigating the Increased Risk of Falls in Individuals With Parkinson's Disease Treated With Deep Brain Stimulation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-80
SponsorUniversity of Alabama at Birmingham

About this trial

The purpose of this pilot study is to assess changes in thinking and movement after deep brain stimulator implantation. The study will also examine whether these changes are related to the risk of falls.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age between 30-80, patient has elected to undergo DBS surgery as part of routine care, cleared for deep brain stimulation surgery as part of routine care by the movement disorders committee. Refractory motor symptoms such as dyskinesias, wearing off, and/or motor fluctuations, causing significant disability, despite reasonable attempts at medical management, as determined by the consensus DBS committee, able to walk, Patient is available for follow-up over the length of the study

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • DBS as part of standard of care

    Behavioral

    Individuals with Parkinson's Disease will be selected to undergo DBS as part of standard of care. Those individuals will be assessed prior to and 3 months after.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: DBS for standard of careExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Self-Reported Falls

Individuals will report retrospective falls and prospective falls after DBS surgery

Time frame
From enrollment to end of study will be 4-5 months

Secondary outcomes

1

Step count

Free living activity prior to and after DBS surgery

Time frame
From enrollment to end of participation will be about 4-5 months

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: