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

Primary Purpose

Parkinson Disease

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Active Comparator: Active tDCS and Active TUS

Sham Comparator: Sham TDCS and Sham TUS

Physical Therapy

About this trial

This is an interventional other trial for Parkinson Disease

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Spaulding Rehabilitation Network Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active tDCS and Active TUS

Sham TDCS and Sham TUS

Arm Description

Active tDCS and Active TUS for 20 min

Sham TDCS and Sham TUS for 20 min

Outcomes

Primary Outcome Measures

Change in postural sway

Postural sway will be assessed through biomechanical assessments using a set of integrated sensors including accelerometers, gyroscopes, force sensors, and motion-capture cameras.

Secondary Outcome Measures

Unified Parkinson's Disease Rating Scale (UPDRS)

Motor function (including tremor, bradykinesia, postural instability and gait), non-motor symptoms, activities of daily living and complications of therapy will be investigated per UPDRS (parts I-IV); staging of PD and ability to perform activities of daily living will also be investigated via UPDRS parts V and VI. We already have experience using this assessment in several previous brain stimulation PD studies.

Leg Agility

kinematic changes will be assessed with kinematic metrics (e.g., speed (m/s)) taken with a biomechanical assessment suite throughout the study.

Arising from a chair

kinematic changes will be assessed with kinematic metrics (e.g., time to complete task) taken with a biomechanical assessment suite throughout the study.

Balance

kinematic changes will be assessed with kinematic metrics taken during a modified Romberg exam (e.g., change in center of pressure over a fixed time interval (cm)) with a biomechanical assessment suite throughout the study.

Gait

changes in the walking speed, gait asymmetry, stride length, walking smoothness, and gait freezing kinematic characteristics (e.g., m/s) will be assessed with a biomechanical assessment suite throughout the study

Toe tapping

kinematic changes will be assessed with kinematic metrics (e.g., speed (m/s)) taken with a biomechanical assessment suite throughout the study.

Full Information

NCT ID

NCT03981055

First Posted

January 28, 2019

Last Updated

August 12, 2022

Sponsor

Spaulding Rehabilitation Hospital

Collaborators

Highland Instruments, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT03981055

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 23, 2020 (Actual)

Primary Completion Date

August 1, 2023 (Anticipated)

Study Completion Date

August 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Spaulding Rehabilitation Hospital

Collaborators

Highland Instruments, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. Study Description

Brief Summary

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)

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson Disease

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Active tDCS and Active TUS

Arm Type

Experimental

Arm Description

Active tDCS and Active TUS for 20 min

Arm Title

Sham TDCS and Sham TUS

Arm Type

Sham Comparator

Arm Description

Sham TDCS and Sham TUS for 20 min

Intervention Type

Device

Intervention Name(s)

Active Comparator: Active tDCS and Active TUS

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham Comparator: Sham TDCS and Sham TUS

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Physical Therapy

Intervention Description

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 Outcome Measure Information:

Title

Change in postural sway

Description

Postural sway will be assessed through biomechanical assessments using a set of integrated sensors including accelerometers, gyroscopes, force sensors, and motion-capture cameras.

Time Frame