Dextroamphetamine and tDCS to Improve the Fluency

NCT02514044 | Completed Phase 2 Results DMC

• 1 other identifier: HSC-MS-14-0354
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study aims to evaluate safety and efficacy of combined dextroamphetamine (Dexedrine) and transcranial direct current stimulation (tDCS) with melodic intonation therapy (MIT) for treatment of aphasia after stroke. The target population is patients with chronic speech deficits due to a left hemisphere non-hemorrhagic stroke. Findings from this proposed project will help in the design of future larger studies.The safety phase will use cross-over, placebo controlled and single-blinded design. 10 participants with post stroke chronic non-fluent aphasia will undergo two experiments. To study the safety and effect of combined dextroamphetamine, tDCS and MIT therapy the study will use a parallel-groups, randomized, sham and placebo controlled, and double-blinded design in which 48 participants with post stroke chronic non-fluent aphasia will be randomly assigned to receive either 1) dextroamphetamine therapy with active stimulation, 2) placebo medication with active stimulation, 3) dextroamphetamine therapy with sham stimulation or 4) placebo medication with sham stimulation for the same duration.

Conditions

Stroke

Outcome Measures

Primary Outcomes (2)

• Percent Change in Language Quotient as Assessed by the Western Aphasia Battery

  The score on the Language Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.

  immediately before the treatment, immediately after the treatment

• Percent Change in Aphasia Quotient as Assessed by the Western Aphasia Battery

  The score on the Aphasia Quotient of the Western Aphasia Battery ranges between 0-100. Higher scores indicate better performance. Below, percent change in the score is reported.

  immediately before the treatment, immediately after the treatment

Secondary Outcomes (3)

• Boston Diagnostic Aphasia Examination

  Baseline,2 weeks

• Boston Diagnostic Aphasia Examination

  Baseline,2 months

• Percent Change in Blood Pressure

  immediately before the treatment, after after the treatment

Study Arms (6)

Dexedrine+sham tDCS+speech therapy

EXPERIMENTAL

10 mg Dexedrine and speech therapy for 10 days

Drug: Dexedrine; Behavioral: Speech Therapy; Device: Sham tDCS

active tDCS+placebo+speech therapy

EXPERIMENTAL

1.5 mA anodal tDCS and speech therapy for 10 days

Device: Active tDCS; Behavioral: Speech Therapy; Drug: Placebo

Dexedrine+tDCS+speech therapy

EXPERIMENTAL

10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 10 days

Drug: Dexedrine; Device: Active tDCS; Behavioral: Speech Therapy

sham stimulation+placebo+speech therapy

EXPERIMENTAL

Sham stimulation, placebo and speech therapy for 10 days

Behavioral: Speech Therapy; Drug: Placebo; Device: Sham tDCS

Dexedrine+tDCS+Speech Therapy

EXPERIMENTAL

10 mg Dexedrine, 1.5 mA anodal tDCS, and speech therapy for 1 day

Drug: Dexedrine; Device: Active tDCS; Behavioral: Speech Therapy

placebo+tDCS+Speech Therapy

EXPERIMENTAL

1.5 mA anodal tDCS, and speech therapy for 1 day

Device: Active tDCS; Behavioral: Speech Therapy; Drug: Placebo

Interventions

Dexedrine DRUG

10 mg immediate release of Dexedrine

Also known as: Adderall, Dexedrine

Dexedrine+sham tDCS+speech therapy; Dexedrine+tDCS+Speech Therapy; Dexedrine+tDCS+speech therapy

Active tDCS DEVICE

1.5 mA tDCS anodal tDCS

Dexedrine+tDCS+Speech Therapy; Dexedrine+tDCS+speech therapy; active tDCS+placebo+speech therapy; placebo+tDCS+Speech Therapy

Speech Therapy BEHAVIORAL

60 min of speech therapy

Also known as: Melodic Intonation Therapy

Dexedrine+sham tDCS+speech therapy; Dexedrine+tDCS+Speech Therapy; Dexedrine+tDCS+speech therapy; active tDCS+placebo+speech therapy; placebo+tDCS+Speech Therapy; sham stimulation+placebo+speech therapy

Placebo DRUG

active tDCS+placebo+speech therapy; placebo+tDCS+Speech Therapy; sham stimulation+placebo+speech therapy

Sham tDCS DEVICE

Dexedrine+sham tDCS+speech therapy; sham stimulation+placebo+speech therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age above 18
• Native English proficiency;
• Nonfluent speech;
• Premorbid right handedness;
• Non-hemorrhagic left hemispheric stroke at least 6 months prior to the investigation.
• No contraindications for MRI (only subjects who will undergo MRI scan).

You may not qualify if:

• Hypersensitivity or idiosyncrasy to dextroamphetamine or to other sympathomimetic agents;
• Pregnant or trying to become pregnant;
• Active alcohol abuse, illicit drug use or drug abuse or significant mental illness;
• Subjects receiving alpha adrenergic antagonists or agonists;
• Any history of epilepsy;
• Any condition that would prevent the subject from giving voluntary informed consent;
• An implanted brain stimulator;
• Aneurysm clip or other metal in the brain;
• Enrolled or plans to enroll in an interventional trial during this study;
• Scalp wounds or infections;
• A concurrent progressive neurologic disorder, acute coronary syndrome, severe heart disease (NYHA Classification \> 3), or other major medical condition;
• Advanced atherosclerosis, Unstable cardiac dysrhythmia or uncontrolled hypertension (\>160/100 mm Hg), or untreated hyperthyroidism;
• Diagnosis of glaucoma
• During or within 14 days following the administration of monoamine oxidase inhibitors;
• Subjects requiring palliative care;

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Dextroamphetamine; Adderall; Speech Therapy

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Amphetamine; Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals; Rehabilitation of Speech and Language Disorders; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics

Limitations and Caveats

The safety phase of the study was completed; however, the efficacy phase was not started.

Results Point of Contact

• Title: Dr. Gerard E. Francisco, Chairman and Professor, Physical Medicine and Rehabilitation
• Organization: University of Texas Health Science Center at Houston (UTHealth)

gerard.e.francisco@uth.tmc.edu

713.797.5246

Study Officials

• Gerard E Francisco, MD

  University of Texas Health Science Center at Houston, Department of Physical Medicine and Rehabilitation

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman and Clinical Professor

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: August 3, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 3, 2018
• Results First Posted: August 3, 2018

Record last verified: 2018-07

Locations

US (1)