Deep Brain StimulationNCT07725315
Investigating the Increased Risk of Falls in Individuals With Parkinson's Disease Treated With Deep Brain Stimulation
A study of Deep Brain Stimulation and PARKINSON DISEASE (Disorder), run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Deep Brain Stimulation, PARKINSON DISEASE (Disorder)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2026to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Exclusion Criteria: Patient's insurance will not cover the costs of surgery with investigational devices, Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions contraindicating DBS surgery or stimulation, self-report of lack of clear levodopa response, requires a walker or wheelchair for mobility
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
UAB WHARF at Lakeshore
Homewood, Alabama, 35294
Alexandra Evancho, PhD, (205) 975-5229, amelgin@uab.edu
About this study
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.
Read the detailed description
Deep brain stimulation (DBS) is an effective 2nd line therapeutic strategy for Parkinson's disease (PD) patients in whom pharmacologic interventions no longer optimally control primary motor symptoms such as rigidity, bradykinesia, and tremor. However, the extent to which DBS improves axial motor symptoms (e.g., postural instability) is equivocal. While some investigations show improved static and dynamic balance measured in the lab, many studies also show that individuals fall at a higher rate compared to those without DBS. Increased incidence of falls reduce participation in the community. Thus, it is important to identify modifiable mechanisms of falls and design interventions that address these factors. However, in many studies investigating balance in PD, DBS is an exclusionary factor. This study addresses a major unmet need in PD therapeutics to identify causal factors that increase fall risk after DBS implantation and programming.
- Being tested
- DBS as part of standard of care
- Keywords
- DBS, Parkinson's disease, Falls
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBS as part of standard of careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| DBS for standard of care | Experimental | Individuals who undergo DBS surgery as part of standard of care will be observed prior to and after DBS surgery and data at these timepoints associated with indicine falls. Receives: Behavioral: DBS as part of standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-Reported Falls
Individuals will report retrospective falls and prospective falls after DBS surgery
Measured: 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
Measured: From enrollment to end of participation will be about 4-5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start1 Aug 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Brain StimulationStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christopher Hurt, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725315
- Sponsor's protocol ID
- IRB-300016843
- Other IDs
- UAB CEDHARS
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Increased Risk of Falls in Individuals With Parkinson's Disease Treated With Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT07725315
- Acronym / sponsor ID
- IRB-300016843
- Keywords
- DBS, Parkinson's disease, Falls
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Deep brain stimulation (DBS) is an effective 2nd line therapeutic strategy for Parkinson's disease (PD) patients in whom pharmacologic interventions no longer optimally control primary motor symptoms such as rigidity, bradykinesia, and tremor. However, the extent to which DBS improves axial motor symptoms (e.g., postural instability) is equivocal. While some investigations show improved static and dynamic balance measured in the lab, many studies also show that individuals fall at a higher rate compared to those without DBS. Increased incidence of falls reduce participation in the community. Thus, it is important to identify modifiable mechanisms of falls and design interventions that address these factors. However, in many studies investigating balance in PD, DBS is an exclusionary factor. This study addresses a major unmet need in PD therapeutics to identify causal factors that increase fall risk after DBS implantation and programming.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DBS for standard of care | Experimental | Behavioral: DBS as part of standard of careIndividuals who undergo DBS surgery as part of standard of care will be observed prior to and after DBS surgery and data at these timepoints associated with indicine falls. |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
- Exclusion Criteria: Patient's insurance will not cover the costs of surgery with investigational devices, Medical contraindications such as current uncontrolled hypertension, heart disease, coagulopathy, or other conditions contraindicating DBS surgery or stimulation, self-report of lack of clear levodopa response, requires a walker or wheelchair for mobility
- -
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBS as part of standard of careIndividuals 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. | Behavioural | DBS for standard of care |
Primary outcome
Self-Reported Falls
Time frame: From enrollment to end of study will be 4-5 months
Individuals will report retrospective falls and prospective falls after DBS surgery
1 secondary outcome
Step count
Time frame: From enrollment to end of participation will be about 4-5 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
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Temporal Interference Methods for Non-invasive Deep Brain Stimulation, Study 1.3
Healthy Volunteers
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Safety and Feasibility of DBS for Bipolar Depression
Bipolar I Disorder, Bipolar Depression
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Intrathecal Baclofen and Pediatric Dystonia
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Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Deep Brain Stimulation and PARKINSON DISEASE (Disorder), run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Hurt, PhD (2059345817, cphurt@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-Reported Falls (time frame: From enrollment to end of study will be 4-5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.