Parkinson's DiseaseTDCS-FOGNCT02266004

Transcranial Direct Current Stimulation for Freezing of Gait

A study testing Transcranial Direct Current Stimulation (tDCS) and locomotor training in people with Parkinson's Disease, run by University of Miami at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This study will evaluate the effects of transcranial direct current stimulation (tDCS) in combination with locomotor training in patients with Parkinson's disease (PD) and freezing of gait (FOG). Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Parkinson's Disease
What is being tested?: Transcranial Direct Current Stimulation (tDCS) and locomotor training
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 9 participants
Where: 1 siteUnited States
Study dates: 12 Sep 2014to 27 Jun 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

age 18- 80
Parkinson's disease stages 2-3 Hoehn and Yahr.
Presence of Freezing of Gait
Stable medication regimen
Time to complete TUG >12 seconds

Who cannot join

medical condition that would interfere with walking and training for 30 minutes
unable to perform timed up and go in the off condition
history of seizures
implanted deep brain stimulator, pacemaker or any other electronic device.
dementia
Adults unable to consent, individuals who are not yet adults (infants, children, teenagers) pregnant women, prisoners will not be considered for participation

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Miami
Miami, Florida, 33136

Other trials in United States

About this study

Official title: Transcranial Direct Current Stimulation for Freezing of Gait in Patients With Parkinson's Disease

This study will evaluate the effects of transcranial direct current stimulation (tDCS) in combination with locomotor training in patients with Parkinson's disease (PD) and freezing of gait (FOG).

Conditions: Parkinson's Disease
Being tested: Transcranial Direct Current Stimulation (tDCS), locomotor training
Keywords: transcranial direct current stimulation, neuromodulation
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial Direct Current Stimulation (tDCS)Device
Also called tDCS
Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.
locomotor trainingOther
An individualized dual-task walking program for approximately 30 minutes.

Study groups in NCT02266004
Study group	Role	What they receive
tDCS+ LT	Experimental	Transcranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks. Receives: Device: Transcranial Direct Current Stimulation (tDCS); Other: locomotor training

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Walking Speed
walking speed will be measured using sensors during a 90 second walk
Measured: baseline, 3 weeks

Secondary outcomes (11)

Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS)
UPDRS motor score range from 0-56 with higher scores indicating greater impairment.
Measured: baseline, 3 weeks
Change in Stride Length
Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk.
Measured: baseline, 3 weeks
Change in Postural Sway
Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing.
Measured: baseline, 3 weeks
Change in Timed Up-and-Go (TUG) Time
Participants are timed while standing up from a chair, walking around a cone, and returning to their chair.
Measured: baseline, 3 weeks
Change in Motor Threshold
Transcranial magnetic stimulation is used to measure motor threshold of the primary motor area. The motor threshold was defined as the minimum intensity needed to evoke 5 out 10 motor evoked potentials in the first dorsal interosseous muscle in the hand.
Measured: baseline, 3 weeks
Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio
Glutamate/GABA ratio will be measured with magnetic Resonance Spectroscopy (MRS).
Measured: baseline, 3 weeks
Change in Backward Digit Span
Digit span is measured by total number of correct digits recited.
Measured: baseline, 3 weeks
Change in the Trail Making Test Time
Trail making test is measured as the number of seconds required to complete the task, with higher scores indicating greater impairment.
Measured: baseline, 3 weeks
Change in the Montreal Cognitive Assessment (MOCA)
The MOCA has a total score ranging from 0-30 with a higher score indicating better performance.
Measured: baseline, 3 weeks
Change in the Auditory Consonant Trigrams Test (ACT)
The ACT has a score from 0-60 with higher score indicating better performance.
Measured: baseline, 3 weeks
Change in the Freezing of Gait Questionnaire (FOG-Q)
The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing.
Measured: baseline, 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 201427 Jun 2018

First posted16 Oct 2014 (estimated)
Study start12 Sep 2014
Primary completion27 Jun 2018
Study completion27 Jun 2018

Why it stopped: difficult to recruit participants

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
More trials run by University of MiamiThe 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: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 9 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02266004
Sponsor's protocol ID: 20140127
Acronym: TDCS-FOG
Status last verified: Jun 2020
First submitted: 7 Oct 2014
Last updated: 30 Jun 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcranial Direct Current Stimulation for Freezing of Gait in Patients With Parkinson's Disease
ClinicalTrials.gov ID: NCT02266004
Acronym / sponsor ID: TDCS-FOG / 20140127
Conditions: Parkinson's Disease
Keywords: transcranial direct current stimulation, neuromodulation
Study type: Interventional
Recruitment status: TerminatedReason stopped: difficult to recruit participants
Enrolment: 9 participants (actual)
Lead sponsor: University of MiamiUniversity, hospital or other
Study start: 12 Sep 2014 (actual)
Primary completion: 27 Jun 2018 (actual)
Study completion: 27 Jun 2018 (actual)
First posted: 16 Oct 2014 (estimated)
Results: Posted 16 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This study will evaluate the effects of transcranial direct current stimulation (tDCS) in combination with locomotor training in patients with Parkinson's disease (PD) and freezing of gait (FOG).

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
tDCS+ LT	Experimental	Device: Transcranial Direct Current Stimulation (tDCS), Other: locomotor trainingTranscranial direct current stimulation(tDCS) plus locomotor training (LT) 3x per week for 3 consecutive weeks.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

age 18- 80
Parkinson's disease stages 2-3 Hoehn and Yahr.
Presence of Freezing of Gait
Stable medication regimen
Time to complete TUG >12 seconds

Key exclusion criteria (6 listed)

medical condition that would interfere with walking and training for 30 minutes
unable to perform timed up and go in the off condition
history of seizures
implanted deep brain stimulator, pacemaker or any other electronic device.
dementia

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
Transcranial Direct Current Stimulation (tDCS)Also: tDCSAnodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.	Device	tDCS+ LT
locomotor trainingAn individualized dual-task walking program for approximately 30 minutes.	Other	tDCS+ LT

Primary outcome

Change in Walking Speed
Time frame: baseline, 3 weeks
walking speed will be measured using sensors during a 90 second walk

11 secondary outcomes

Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: baseline, 3 weeks
Change in Stride Length
Time frame: baseline, 3 weeks
Change in Postural Sway
Time frame: baseline, 3 weeks
Change in Timed Up-and-Go (TUG) Time
Time frame: baseline, 3 weeks
Change in Motor Threshold
Time frame: baseline, 3 weeks
Change in Glutamate/Gamma Aminobutyric Acid(GABA) Ratio
Time frame: baseline, 3 weeks
Change in Backward Digit Span
Time frame: baseline, 3 weeks
Change in the Trail Making Test Time
Time frame: baseline, 3 weeks
Change in the Montreal Cognitive Assessment (MOCA)
Time frame: baseline, 3 weeks
Change in the Auditory Consonant Trigrams Test (ACT)
Time frame: baseline, 3 weeks
Change in the Freezing of Gait Questionnaire (FOG-Q)
Time frame: baseline, 3 weeks

Results and safety

Results posted to the registry on 16 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
tDCS+ LT	9	7

Primary outcome: Change in Walking Speed

Time frame: baseline, 3 weeks. Mean (Standard Deviation). Unit: m/s

Measure	tDCS+ LT n = 2
Value	0.169 (0.244)

Population analysed: Unable to retrieve collected data on the other 5 participants who completed the study due to a malfunction in the sensors.

11 secondary outcomes are reported in the full results.

Adverse events

Time frame: 3 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
tDCS+ LT	1 of 9 (11.1%)	1 of 9 (11.1%)	0 of 9

Limitations and caveats (from the sponsor): Data was not collected on 4 of the outcome measures due to lack of funding which contributed to the difficulty in performing the tests required per protocol.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Corneliu Luca, MD, PhD principal investigator

University of Miami

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Direct Current Stimulation (tDCS) and locomotor training in people with Parkinson's Disease, run by University of Miami 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 30 Jun 2020. 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?

Yes. Results are posted in the registry (first posted 16 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Walking Speed (time frame: baseline, 3 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02266004.

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 30 Jun 2020.