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Active, Not Recruiting

NCT Number: NCT03981055

Parkinson's Disease: Enhancing Physical Therapy With Brain Stimulation for Treating Postural Instability.

This trial aims to understand the mechanism and to test whether transcranial direct current stimulation (tDCS) combined with transcranial ultrasound (TUS) (tDCS+TUS) combined with physical therapy (PT) will induce significant therapeutic effects in postural instability in Parkinson's disease (PT) patients. The investigators designed a double-blinded, placebo controlled, randomized study to investigate the effects of 2 weeks of TDCS+TUS on postural instability in PD patients receiving PT. (Followed by biweekly sessions for 2 more weeks in Phase II)

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

40 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Spaulding Rehabilitation Network Research Institute

Charlestown, Massachusetts, 02129, United States

About this study

Current treatments for Parkinson's Disease (PD), including pharmacological (levodopa) and surgical (DBS) methods, have limited impact on postural instability. Physical therapy (PT) for PD is becoming increasingly used as a means to induce benefits on patient balance. However, limits in efficacy and consistency still exist. In this study, the investigators will test the effects of TDCS+TUS combined with PT on postural instability of PD patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of "probable" or "possible" PD, as defined by the current clinical criteria (Gelb D, Oliver E, Gilman S. Diagnostic Criteria for Parkinson's Disease. Arch Neurol.1999;56:33-39) as confirmed by co-investigator neurologist, or confirmation via medical records or a letter from patient physician;
  • Complaints about balance impairment or postural instability due to PD (self-report);
  • Age from 40 to 90 years old;
  • Taking stable medications for PD for at least 30 days.

Exclusion criteria

  • Features suggestive of other causes of parkinsonism/Parkinson's-plus syndromes;
  • History of deep brain stimulation or brain ablation surgeries, malignant mass brain lesions;
  • History of schizophrenia, bipolar illness; history of alcohol/drug abuse within the past 6 months;
  • Need for rapid clinical response due to conditions such as initiation, psychosis, or suicidality;
  • Contraindications to transcranial brain stimulation or TUS, i.e. metal in the head, implanted brain medical devices, etc.;
  • Unstable medical conditions (e.g., uncontrolled diabetes, uncompensated cardiac issues, heart failure, uncompensated pulmonary disease, or chronic obstructive pulmonary disease);
  • Pregnancy.
  • Epilepsy or disorders that significantly increase likelihood of seizures including: severe traumatic brain injury, congenital birth defects leading to seizures, brain tumor, metabolic disorders associated with seizures, intracranial or subarachnoid hemorrhage, and nonlacunar strokes.
  • Recent (<= 2 months) or planned enrollment in an additional physician prescribed physical therapy program during their time in the trial.
  • Presence of another disorder that might have a significant impact on balance (as assessed by a co-investigator neurologist).
  • Bed or wheelchair-bound

Treatment and study plan

Active Comparator: Active tDCS and Active TUS

Device

Device: Transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.

Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

Sham Comparator: Sham TDCS and Sham TUS

Device

Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.

Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.

Physical Therapy

Other

All subjects will enroll in a conventional PT balance and gait focused training program, and will receive PT 3x/week over the two weeks of stimulation for 45 minutes following the stimulation sessions when applicable. (And during the biweekly sessions for Phase II)

Primary outcomes

  1. Improvement in Unified Parkinson's Disease Rating Scale (UPDRS) Part III

    Time frame: Change from baseline to Day 14 (end of stimulation treatment).

    Motor function was assessed using the Unified Parkinson's Disease Rating Scale (UPDRS) Part III - Motor Examination, which measures tremor, rigidity, bradykinesia, postural instability, and gait.

    Scores range from 0 to 108, where higher scores indicate worse motor impairment (i.e., lower scores represent better motor function).

Sponsors and collaborators

Lead sponsor

Spaulding Rehabilitation Hospital

Other

Collaborators

  • Highland Instruments, Inc.
  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Jun 10, 2019
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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