NCT02266004: TDCS-FOG

Transcranial Direct Current Stimulation for Freezing of Gait

Terminated NA Results posted Last updated 30 June 2020

What this trial tests

NA trial testing Transcranial Direct Current Stimulation (tDCS) in Parkinson's Disease in 9 participants. Terminated before completion.

Timeline

12 September 2014

Primary endpoint
27 June 2018

27 June 2018

Quick facts

Lead sponsor	University of Miami
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	12 September 2014
Primary completion	27 June 2018
Estimated completion	27 June 2018
Sites	1 location across United States

Drugs / interventions tested

• Transcranial Direct Current Stimulation (tDCS)
• locomotor training

Conditions studied

• Parkinson's Disease — all drugs for Parkinson's Disease →

Sponsor

University of Miami

Who can join

Adults 18 to 80, any sex, with Parkinson's Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Walking Speed Primary · baseline, 3 weeks

walking speed will be measured using sensors during a 90 second walk

Group	Value	95% CI
tDCS+ LT	0.169	± 0.244

Change in Motor Scores as Measured by Unified Parkinson's Disease Rating Scale (UPDRS) Secondary · baseline, 3 weeks

UPDRS motor score range from 0-56 with higher scores indicating greater impairment.

Group	Value	95% CI
tDCS+ LT	-1.714	± 14.088

Change in Stride Length Secondary · baseline, 3 weeks

Stride length is measured with mobile sensors attached to participant's extremities during the 90 second walk.

Group	Value	95% CI
tDCS+ LT	0.127	± 0.239

Change in Postural Sway Secondary · baseline, 3 weeks

Postural sway is measured with mobile sensors attached to participant's extremities during the 30 seconds of quiet standing.

Group	Value	95% CI
tDCS+ LT	-0.012	± 0.009

Change in Timed Up-and-Go (TUG) Time Secondary · baseline, 3 weeks

Participants are timed while standing up from a chair, walking around a cone, and returning to their chair.

Group	Value	95% CI
tDCS+ LT	-6.878	± 4.268

Change in Motor Threshold Secondary · baseline, 3 weeks

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.

Group	Value	95% CI
tDCS+ LT	-0.005	± 0.021

Change in the Montreal Cognitive Assessment (MOCA) Secondary · baseline, 3 weeks

The MOCA has a total score ranging from 0-30 with a higher score indicating better performance.

Group	Value	95% CI
tDCS+ LT	2.57	± 1.89

Change in the Freezing of Gait Questionnaire (FOG-Q) Secondary · baseline, 3 weeks

The FOG-Q has a total score ranging from 0-24 with higher scores indicating more incidents of freezing.

Group	Value	95% CI
tDCS+ LT	-4.29	± 3.21

Adverse events — posted to ClinicalTrials.gov

Time frame: 3 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

tDCS+ LT

Serious: 1/9 (11%)

Deaths: 0/9

Serious adverse events (1 terms)

Reaction	System	tDCS+ LT
dizziness	Nervous system disorders	—

Other adverse events (2 terms — click to expand)

Reaction	System	tDCS+ LT
fall at home	Musculoskeletal and connective tissue disorders	—
fatigue	Musculoskeletal and connective tissue disorders	—

Most-reported serious reactions: dizziness.

Data from ClinicalTrials.gov NCT02266004 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Transcranial direct current stimulation (tDCS) for idiopathic Parkinson's disease.
   Elsner B, Kugler J, Pohl M, Mehrholz J. · · 2016 · cited 38× · PMID 27425786 · DOI 10.1002/14651858.cd010916.pub2