Dual Transcranial Direct Current Stimulation (dTDCS)-Enhanced Therapy After Hemorrhagic Strokes and VEGF

NCT03857243 | Terminated Results

• 2 other identifiers: 14GRNT18690039STU 012014-028
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

This study will evaluate the feasibility of dual tDCS to improve arm motor function in chronic stroke patients. In addition it will collect pilot data on the blood biomarkers associated with treatment effect.

Conditions

Hemorrhagic Stroke; Hemiparesis

Outcome Measures

Primary Outcomes (2)

• Adverse Events

  any adverse events that might be related to study procedures

  enrollment to 3 month followup

• Upper Extremity Fugl-Meyer Score

  Upper extremity motor impairment scale. Scale ranges from 0 (worst, can not perform any tasks) to 66 ( performs all tasks fully).

  change between before and 3 months follow-up

Secondary Outcomes (1)

• Wolf Motor Function Test

  change between before and at 3 months follow-up

Study Arms (2)

dTDCS plus physical therapy

EXPERIMENTAL

active dual transcranial direct current stimulation (TDCS) arm (M1-M1)

Device: dual transcranial direct current stimulation

Sham dTDCS plus physical therapy

PLACEBO COMPARATOR

Non-effective dose dual TDCS stimulation arm, identical with intervention arm except for the stimulation intensity/duration used.

Device: dual transcranial direct current stimulation

Interventions

dual transcranial direct current stimulation DEVICE

Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed.

Also known as: dtDCS,, dual tDCS

Sham dTDCS plus physical therapy; dTDCS plus physical therapy

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (18-85 yo) with arm weakness (uFM \<60) as a result of an ICH and no history of other neurologic or psychiatric illness that are able to activate wrist flexors (\> MRC 1);
• Patients with symptomatic ICH \>5 months before enrollment;
• Ashworth spasticity score \<3.

You may not qualify if:

• Patients with severe uncontrolled medical problems,
• Patients with subarachnoid, subdural or epidural hemorrhage;
• Patients with unstable cardiac arrhythmia;
• Patients with contraindication to tDCS stimulation;
• Patients who are not available for follow-up or unable to follow study procedures;
• Pregnancy

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• American Heart Association: collaborator

Study Sites (1)

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Hemorrhagic Stroke; Paresis

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination due to PI relocation, low recruitment.

Results Point of Contact

• Title: Timea Hodics, M.D.
• Organization: UTSW

Timea.Hodics@UTSouthwestern.edu

(240)-423-2741

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2017
• First Posted: February 27, 2019
• Study Start: January 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: April 17, 2017
• Last Updated: November 18, 2019
• Results First Posted: November 18, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)