Active — Not RecruitingPhase 1

Enhancing Gait Using Alternating-Frequency DBS in Parkinson Disease

United States12 participantsStarted 2021-10-04

Plain-language summary

The purpose of this study is to assess how alternating-frequency Deep Brain Stimulation (DBS) works to improve postural instability and gait, while also treating other motor symptoms of Parkinson Disease (PD).

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Bilateral STN DBS for PD * Medtronic Percept PC implanted DBS battery/pulse generator/recording system * Presence of balance and/or walking impairment and/or freezing of gait * Can walk without assistance, OFF meds, based on yes/no verbal response Exclusion Criteria: * Severity of gait impairment should not require dependency to walker or cane * Cannot tolerate monopolar stimulation at either of the two middle electrode contacts (prerequisite for the recording mode of the DBS) at high frequency (130 Hz) or low frequency (60 Hz). * Concomitant conditions that may affect significantly the evaluation of balance or gait, including orthopedic, rheumatologic or other neurological diseases * Contraindication to physical therapy * Age \< 21 * Diagnosis of dementia * Not agreeable to having video taken of entire research visit

What they're measuring

Stride Time Coefficient of Variation

Timeframe: During the intervention

Percentage of Time with Tremor Present

Timeframe: During the intervention

Tremor Amplitude

Timeframe: During the intervention

Trial details

NCT IDNCT05022147

SponsorJames Liao

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-15

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